• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for December 14, 2011

 

December 14, 2011                                                                                                 11-50
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT
Ocean Cosmeceuticals, J Hansyd Elite Face Lotion, 1oz, 29mL, MW Labs. Recall # F-0120-2012
CODE
Lot# 020910
RECALLING FIRM/MANUFACTURER
M W Laboratories Inc., Savannah, GA, by letter on September 21, 2011. Firm initiated recall is ongoing.
REASON
The incorrect ingredient deck was printed on the Elite Face Lotion label.
VOLUME OF PRODUCT IN COMMERCE
55/ 1 oz bottles
DISTRIBUTION
GA, MA and SC
___________________________________
PRODUCT
1) Alfa Creams, Gel de Caracol, Baba de Caracol, a) Net Weight 4 oz. (113.4g), UPC Code: 6 76194 50060 4, b) Net Weight 8 oz. (226.8g), UPC Code: 6 76194 50074 1, External Use Only. Recall # F-0263-2012;
 
2) Lawrens, Gel de Caracol, Baba de Caracol, 8 oz. (228mL), External Use Only, UPC Code: 6 76194 23025 9. Recall # F-0264-2012
CODE
1) Lot #: a) 2750, Exp 12/11; b) 2356, Exp 02/12;
2) Lot #: 2400
RECALLING FIRM/MANUFACTURER
Pharmacreams Corp., Doral, FL, by letter on March 11, 2011 and by fax on March 17, 2011. FDA initiated recall is ongoing. 
REASON
Products may have the potential for microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
2,718 units
DISTRIBUTION
Venezuela, Honduras and NY, and FL
___________________________________
PRODUCT
100% Pure Cocoa Plum Fruit Pigmented Eye Shadow. Recall # F-0268-2012
CODE
Bot 1B11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purity Cosmetics, San Jose. CA, by press release on October 31, 2011 and letters on November 3, 2011.
Manufacturer: Radical Cosmetics, New Brunswick, NJ. FDA initiated recall is ongoing.
REASON
FDA samples confirmed the presence of Pseudomonas luteola in Cocoa Plum colored eye shadow.
VOLUME OF PRODUCT IN COMMERCE
502 units
DISTRIBUTION
Nationwide, and Canada, Slovenia, South Africa, Romania, Kazakhstan
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS III
___________________________________
PRODUCT
SK-II Skin Signature Eye Cream - Moisturizing Recovery Cream, 15 ml glass jars inside paperboard printed carton; UPC 4979006052053. Recall # F-0388-2012
CODE
Lot #'s: 10944211801 & 1126211802
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble. Cincinnati, OH, by letters on October 26, 2011.
Manufacturer: Procter & Gamble Cosmetic, Yasu-Cho, Shiga, Japan. Firm initiated recall is ongoing.
REASON
Several consumer containers of SK-II Skin Signature Eye Cream Moisturizing Recovery Cream was released to to the market with only Japanese language on the product.
VOLUME OF PRODUCT IN COMMERCE
475/15 ml jars
DISTRIBUTION
AZ, CA, FL, HI, IA, IL, MA, MD, NJ, NV, NY, TX and VA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Chocolate Covered Mixed Fruit is packed in clear cellophane bag and each bag has a net wt. 2 oz. The UPC is 0 19815 00013 6. The product also sold to retailers in 1 lb. bag. There is no UPC on this bag. The product is labeled in parts: "***Chocolate Covered MIXED FRUIT***DAIRY FREE***GLUTEN FREE***Net Wt. 2 oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), apricots, pears, apples, cranberries, sulfur dioxide, sunflower oil***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1853-2011;
 
2) Chocolate Covered Roasted Nuts is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00011 2. The product also distributed in 1 lb. bag. There is no UPC on it. The product is labeled in parts: "***Chocolate Covered Roasted Nuts***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), Almonds, Cashew, Hazelnuts, Brazil Nuts***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1854-2011;
 
3) Pure Dark Chocolate Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00014 3. The product is labeled in parts: "***Pure Dark CHOCOLATE Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla)*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1855-2011;
 
4) Chocolate Covered Pretzels is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 70005 0. The product is also sold in 1 lb. bag. There is no UPC on it. The product is labeled in parts: "***Chocolate Covered Pretzels***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla)***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1856-2011;
 
5) Chocolate Espresso Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10002 7. The product is also sold in 1 lb. bag and there is no UPC on it. The product is labeled in parts: "***Chocolate Espresso Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), ground organic espresso coffee***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1857-2011;
 
6) Chocolate Covered Almond Clusters is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00024 2. The product is also sold in 1 lb. bag and there is no UPC on it. The product is labeled in parts: "***Chocolate Covered Almond Clusters***DAIRY FREE***GLUTEN FREE***Net Wt. 2 oz (56.7G) *** INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), Almonds***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1858-2011;
 
7) Chocolate Covered Raisin Clusters is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00025 9. The product is labeled in parts: "***Chocolate Covered Raisin Clusters***DAIRY FREE***GLUTEN FREE***Net Wt. 2 oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), raisins***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1859-2011;
 
8) Chocolate Mint Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00021 1. The product is also sold in 1 lb. bag and there is no UPC on it. The product is labeled in parts: "***Chocolate Mint Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), peppermint oil***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1860-2011;
 
9) Chocolate Peanut Butter Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00022 8. The product is also sold 1 lb. bag and there is no UPC on it. The product is labeled in parts: "***Chocolate Peanut Butter Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), organic peanut butter***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1861-2011;
 
10) Chocolate Raspberry Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00020 4. The product is labeled in parts: "***Chocolate Raspberry Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), organic raspberry flavoring oil (organic canola oil, organic coconut oil, organic olive oil, and organic palm fruit oil)*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1862-2011;
 
11) Chocolate Coconut Buttons is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00023 5. The product is labeled in parts: "***Chocolate Coconut Buttons***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), roasted coconut (contains coconut, sugar, water, propylene glycol (sustains freshness), salt, sodium metabisulfite (preserves whiteness)***CHOCOLATE.THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1863-2011;
 
12) Chocolate Covered Cranberry Clusters is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 00026 6. The product is labeled in parts: "***Chocolate Covered Cranberry Clusters***DAIRY FREE***GLUTEN FREE***Net Wt. 2 oz (56.7G)***INGREDIENTS: Semi-sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), cranberries, sugar, sunflower oil*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1864-2011
 
13) Mint Chocolate Covered Pretzels is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 19815 90006. The product is labeled in parts: "***Mint Chocolate Covered Pretzels***DAIRY FREE***GLUTEN FREE***Net Wt. 2oz (56.7G)***INGREDIENTS: Sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), organic pretzels (organic unbleached wheat flour, organic rye flour, organic brown rice syrup, organic sunflower oil, organic barley malt, yeast, salt and sodium bicarbonate), peppermint oil*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1865-2011;
 
14) Chocolate Covered Caramel is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 30003 8. The product is labeled in parts: "***Chocolate Covered Caramel***DAIRY FREE***GLUTEN FREE***Net Wt. 2 oz (56.7G)*** INGREDIENTS: Brown sugar (sugar, inverted sugar syrup and cane molasses), soy milk, washed cane sugar, corn syrup (corn syrup, high fructose corn syrup, salt, vanilla), soy margarine, sweet chocolate (contains sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsifier, vanilla), corn starch, vanilla (vanilla bean extractives in water, alcohol (35%) and sugar***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1866-2011;
 
15) Amaretto Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10033 1. The product is labeled in parts: "***Amaretto Truffles***Always Dairy-Free (Vegan)***Net Wt. 2oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, vanilla, natural & artificial amoretto.” Recall # F-1867-2011;
 
16) Cherry Truffles is packed in clear cellophane bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10031 7. The product is labeled in parts: "***Cherry Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet Chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, natural & artificial cherry flavoring.” Recall # F-1868-2011;
 
17) Double Chocolate Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10037 9. The product is labeled in parts: "***DOUBLE Chocolate Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, vanilla.” Recall # F-1869-2011;
 
18) Espresso Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10038 9. The product is labeled in parts: "*** Espresso Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, organic espresso coffee, vanilla.” Recall # F-1870-2011;
 
19) Raspberry Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10038 9. The product is labeled in parts: "***Raspberry Truffles***Always Dairy-Free (Vegan)***Net Wt. 2oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, vanilla, natural & artificial raspberry flavoring.” Recall # F-1871-2011;
 
20) Rum Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10035 5. The product is labeled in parts: “***Rum Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, vanilla, natural & artificial rum flavoring (propylene glycol, alcohol, water).” Recall # F-1872-2011;
 
21) Cherry Pecan Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10034 8. The product is labeled in parts: "***Cherry Pecan Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, pecans, cherry flavoring.” Recall # F-1873-2011;
 
22) Mint Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10036 2. The product is labeled in parts: "***Mint Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, corn syrup, vanilla, natural peppermint oil.” Recall # F-1874-2011;
 
23) Peanut Butter Truffles is packed in clear striped bags. Each bag has a net wt. 2 oz. The UPC is 0 19815 10032 4. The product is labeled in parts: "***Peanut Butter Truffles***Always Dairy-Free (Vegan)***Net Wt. 2 oz***Ingredients: Sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), soy milk, organic peanut butter, vanilla.” Recall # F-1875-2011;
 
24) Chocolate Almond Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.8 oz. The UPC is 0 19815 80001 9. The product is labeled in parts: "***Chocolate Almond Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), almond. ***CONTAINS: Nuts*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1876-2011
 
25) Chocolate Espresso Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.8 oz. The UPC is 0 19815 80003 3. The product is labeled in parts: "***Chocolate Espresso Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), ground organic espresso coffee*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1877-2011;
 
26) Chocolate Fruit Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net Wt. 2.8 oz. The UPC is 0 19815 80002 6. The product is labeled in parts:"***Chocolate Fruit Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), apricots, pears, apples, cranberries, sulfur dioxide, sunflower oil***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1878-2011;
 
27) Pure Dark Chocolate Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.8 oz. The UPC is 0 19815 80004 0. The product is labeled in parts: "***Pure Dark Chocolate Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla)***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1879-2011;
 
28) Chocolate Pretzel Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.8 oz. The UPC is 0 19815 80005 7. The product is labeled in parts: "***Chocolate Pretzel Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), organic pretzels (organic unbleached wheat flour, organic rye flour, organic brown rice syrup, organic sunflower oil, organic barley malt, yeast, salt, and sodium bicarbonate)*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1880-2011;
 
29) Chocolate Trail Mix Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.0 oz. The UPC is 0 19815 52766 4. The product is labeled in parts: "***Chocolate Trail Mix Bar***DAIRY FREE*** Net Wt. 2.0 oz***Ingredients: Trail mix (rolled oats, high maltose corn syrup, crisp rice (rice, flour, sugar, malt, salt), almonds, raisins, honey, roasted peanuts, sugar, high fructose corn syrup, fructose, sunflower seeds, canola oil, cranberries, maltodextrin, soy lecithin, salt, natural flavor, baking soda, caramel color (mixed tocopherols added to retain freshness), sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla)***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1881-2011;
 
30) Mint Chocolate Bar is wrapped in silver foil and the finished label is wrapped on the outside. Each bar has a net wt. 2.8 oz. The UPC is 0 19815 80005 7. The product is labeled in parts: "***Mint Chocolate Bar 59% CACAO***DAIRY FREE***GLUTEN FREE***Net Wt. 2.8 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), organic peppermint oil (organic canola oil, organic coconut oil, organic olive oil, and organic palm fruit oil) ***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1882-2011;
 
31) Chocolate Covered Coconut Balls are packed in special boxes or clear cellophane bags and sold on internet. Each bag has a net wt. 2.0 oz. The UPC is 0 19815 90007 8. The product is labeled in parts: "***Chocolate Covered Coconut Balls***DAIRY FREE***GLUTEN FREE***Net Wt. 2.0 oz***Ingredients: Powdered sugar (sugar, corn starch), coconut (contains coconut, sugar, water, propylene glycol (sustains freshness), salt, sodium metabisulfite, (preserves freshness), soy milk, soy margarine, washed cane sugar, sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), corn starch ***THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1883-2011;
 
32) Chocolate Covered Peanut Butter Balls are packed in special boxes or clear cellophane bags and sold on internet. Each bag has a net wt. 2.0 oz. The UPC is 0 19815 90001 6. The product is labeled in parts: "***Chocolate Covered Peanut Butter Balls***DAIRY FREE***GLUTEN FREE***Net Wt. 2.0 oz***Ingredients: Powdered sugar (sugar, corn starch), coconut (contains coconut, sugar, water, propylene glycol (sustains freshness), salt, sodium metabisulfite, (preserves freshness), soy milk, soy margarine, washed cane sugar, sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), corn starch *** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***". Recall # F-1884-2011;
 
33) Chocolate Covered Dried Strawberries are packed in special boxes or clear cellophane bags and sold on internet. Each bag has a net wt. 2.0 oz. The UPC is 0 19815 90008 5. The product is labeled in parts: "***Chocolate Covered Dried Strawberries***DAIRY FREE***GLUTEN FREE***Net Wt. 2.0 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), strawberry, sugar, citric acid, sulfur, color (FD&C Red 40)*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS***.” Recall # F-1885-2011;
 
34) Chocolate Covered Gummi Bears are packed in special boxes or clear cellophane bags and sold on internet. Each unit has a net wt. 2.0 oz. The UPC is 0 19815 90009 2. The product is labeled in parts: "***Chocolate Covered Gummi Bears***DAIRY FREE***GLUTEN FREE***Net Wt. 2.0 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), corn malt syrup, juice concentrates (may contain apple, apricot, aronia, carrot, cranberry, elderberry, lemon or red beef), spinach powder, apple pectin, citric acid, natural fruit flavors, carnauba wax (from palm leaves), expeller-pressed sunflower oil*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS". Recall # F-1886-2011;
 
35) Gluten-Free Chocolate Covered Pretzels are packed in special boxes or clear cellophane bags and sold on internet. Each bag has a net wt. 2.0 oz. The UPC is 0 19815 72000 3. The product is labeled in parts: "*** Gluten-Free Chocolate Covered Pretzels***DAIRY FREE***GLUTEN FREE***Net Wt. 2.0 oz***Ingredients: Semi-sweet chocolate (contains: sugar, unsweetened chocolate, cocoa butter, soy lecithin-an emulsified, vanilla), gluten-free pretzels (corn starch, potato starch, palm oil, sugar, sea salt, cellulose gum, soy lecithin, sodium bicarbonate, yeast extract, sodium acid pyrophosphate, citric acid, sodium hydroxide. May contain traces of sesame)*** THIS PRODUCT IS MANUFACTURED IN A PLANT THAT PROCESSES SOY, PEANUTS, OTHER TREE NUTS, AND WHEAT PRODUCTS". Recall # F-1887-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Chocolate Decadence, Eugene, OR, by telephone, e-mail and press release on September 12, 2011. Firm initiated recall is ongoing.
REASON
Product may contain milk and the labels do not declare milk.
VOLUME OF PRODUCT IN COMMERCE
Total 4761 Bars; 5955 Packages (2 oz); 1684 Lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) "***TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***". Recall # F-0109-2012;
 
2) "***TRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)*** 12ct***Keep refrigerated***". Recall # F-0110-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Pastry Food Products Inc., San Juan, PR, by letter on August 29, 2011. FDA initiated recall is ongoing.
REASON
Product Public Reason for Recall :
Undeclared milk as the source of cheese.
VOLUME OF PRODUCT IN COMMERCE
1) 45 boxes (12 ct); 2) 3 boxes (12 ct)
DISTRIBUTION
PR
___________________________________
PRODUCT
"Magellan" HERRING special salting, Net wt. 48.58 oz. (1300g) -- PRODUCT OF RUSSIA --- The Herring special salting is packaged in an uncoded plastic container. Recall # F-0123-2012
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Euphoria Fancy Food Inc., Brooklyn, NY, by press release on July 20, 2011, followed up by letters.
Manufacturer: TH Leader Expo LLC, Moscow, Russia. New York initiated recall is complete.
REASON
The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
99 cases (6 x 1300 g containers per case)
DISTRIBUTION
NY, NJ, SC, FL, TX, IL, MN, OR and CA
___________________________________
PRODUCT
1) HEB Chef Prepared Garden Salad, Small and Large; the products are packaged in-store and have only an ingredient/price and PLU affixed. Includes UPC codes PLU/UPC: 26244200000 and PLU/UPC: 26244300000. Recall # F-0228-2012;
 
2) HEB Chef Prepared Chef Salad, Small and Large; the products are packaged in-store and have only an ingredient/price and PLU affixed. Includes UPC Codes PLU/UPC: 26244400000 and PLU/UPC: 26244500000. Recall # F-0229-2012;
 
3) HEB Chef Prepared Rotisserie Chicken Garden Salad, Small; the products are packaged in-store and have only an ingredient/price and PLU affixed. PLU/UPC: 26244900000. Recall # F-0230-2012; 
 
4) HEB Chef Prepared Roast Turkey Salad, Small; the products are packaged in-store and have only an ingredient/price and PLU affixed. PLU/UPC: 26245000000. Recall # F-0231-2012;
 
5) HEB Chef Prepared Cobb Salad, Large; the products are packaged in-store and have only an ingredient/price and PLU affixed. PLU/UPC: 26245100000. Recall # F-0232-2012
CODE
none
RECALLING FIRM/MANUFACTURER
He Butt Grocery Co., San Antonio, TX, by press release and letter on October 19, 2011. Firm initiated recall is ongoing.
REASON
The HEB Spring Mix, 5 oz container, which was recalled as a part of the Taylor Farms recall for Salmonella may have been used as a part of salads assembled in their stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
TX
___________________________________
PRODUCT
Medium, Large, Extra-Large and Jumbo sized Organic Brown Eggs packed into 6 count, 12 count, 18 count cartons and bulk/flats. Cartons are labeled with the following names: Larry Schultz Organic Farm, Kowalski's, and Lunds & Byerly's. Recall #F-0267-2012
CODE
On or before Julian date 286 EXP NOV 12
RECALLING FIRM/MANUFACTURER
Larry Schultz Organic Farm, LLC, Owatonna, MN, by press release and telephone on October 19, 2011. Minnesota initiated recall is ongoing.
REASON
Eggs have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,502,460 eggs
DISTRIBUTION
MI, MN, and WI
___________________________________
PRODUCT
1) Landshire Nike All-American Salami, Bologna, 96% Fat Free Ham and Swiss Cheese on a Sesame Seed Sub Roll Sandwich, Net Wt. 7.25 oz. (206 g); a refrigerated prepackaged individually wrapped sandwich, 12 sandwiches per case; UPC 0 97488 01741 5. Recall # F-0269-2012;
 
2) Landshire Nike Super Poor Boy Sandwich, Net Wt. 7.25 oz. (206g); a refrigerated prepackaged individually wrapped sandwich, 12 sandwiches per case and 24 sandwiches per case; UPC 0 97488 00001 1. The poor boy sandwiches were also sold in 2 count packs - UPC 0 97488 00765 2 (18 sandwiches per case), and 8 count packs (72 sandwiches per case) - UPC 0 97488 00712 6. Recall # F-0270-2012
CODE
Lots "11 237 6" through"11 285 6" stamped in black ink on the red plastic wrapper.
RECALLING FIRM/MANUFACTURER
Landshire Inc., Caseyville, IL, by press release on October 21, 2011, and October 26, 2011. North Carolina initiated recall is ongoing.
REASON
The sandwiches were found to be contaminated with Listeria monocytogenes bacteria based on the North Carolina Department of Agriculture's analysis.
VOLUME OF PRODUCT IN COMMERCE
18,551 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Product was packaged in 18 lb Wooden Boxes (40-60 count) (Bloaters). Product labeled in part: "***18 LBS 8.2 KG NET SALTED SMOKED SPLIT HERRING***1171 *** CA-00205 HT***REG # 2406***PRODUCT OF CANADA***" Recall # F-0360-2012
CODE
Lot # 1171
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quirch Foods Co., Miami, FL, by letter dated October 20, 2011.
Manufacturer: Leslie Leger & Sons, Cap Pele, Canada. FDA Initiated recall is ongoing.
REASON
Uneviscerated fish pose a potential hazard for Clostridium Botulinum.
VOLUME OF PRODUCT IN COMMERCE
344 cases
DISTRIBUTION
GA, FL, PR
___________________________________
PRODUCT
Product is labeled in part: "SALTED SMOKED SPLIT HERRING***REG No. 4108-2931***CA-00282 KD-HT***PACKED FOR CAP-PELE HERRING EXPORT INC. CAP-PELE, NB 34N 1C2***PRODUCT OF CANADA 18 LBS 8.2 KG NET***" Secondary stick on label reads in part: "***PACKR BLOATER SMKD WOOD CASE 18.00LB***1130118681***Pallet: 1130118666***18666***746000***" REG No: 4108 was identified, by representatives of Cap-Pele, as the plant. 2931 was identified, by representatives of Cap-Pele, as the lot number. Recall # F-0361-2012
CODE
Lot # 2931
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quirch Foods Co., Miami, FL, by telephone beginning November 17, 2011, by letters on November 21, 2011 and by press release on November 22, 2011.
Manufacturer: Petit Cap Fisheries Ltd, Petit-cap New Brunswick, Canada. FDA initiated recall is ongoing.
REASON
FDA laboratory analysis found the product to be uneviscerated. Product presents a potential C. botulinum.
VOLUME OF PRODUCT IN COMMERCE
69 cases
DISTRIBUTION
FL and VI
___________________________________
PRODUCT
Smucker's Natural Peanut Butter, 16 oz glass jar, Lots: 1307004 Best if used by: Aug. 3, 2012 & 1308004 Best if used by: Aug. 4, 2012; UPC code: 0 51500 01701 2. Recall # F-0362-2012
CODE
Lots: 1307004 Best if used by: Aug. 3, 2012 & 1308004 Best if used by: Aug. 4, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: J M Smucker Co, Orrville, OH, by letters on November 16, 2011.
Manufacturer: J.M. Smucker LLC, New Bethlehem, PA. Firm initiated recall is ongoing.
REASON
Product tested positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,619 cs/12/16 oz glass jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Hill Country Fare Cream Cheese Jalapeno Bites, Net Wt. 5.5 oz (156g). Packaged 8 per a carton. UPC 4122081881. Recall # F-0373-2012;
 
2) Hill Country Fare Cheddar Cheese Jalapeno Bites, Net Wt. 5.5 oz (156g). Packaged 8 per a carton. Recall # F-0374-2012
CODE
All product sold prior to 08/05/11. 
RECALLING FIRM/MANUFACTURER
Trans Pecos Foods, LP, Pecos. TX, by press release and letter dated August 5, 2011. Firm initiated recall is ongoing.
REASON
The product contains undeclared soy flour.
VOLUME OF PRODUCT IN COMMERCE
1) 571 cases; 2) 1673 cases
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Shi Shen Tang Mahuang & Cimicifuga Combination; Barcode on label: N/A Item # 20217; Mfg No. CP10217, Use By: 12/2013; Inventory on Hand: 6 x 100g labeled bottles. Product is packaged in a white, plastic bottles with a white affixed label with black, red, and blue printing that reads from left to right, "DIRECTIONS: Take 2-3 grams three times a day***20217***IMPORTED BY:FINEMOST CORP.***QUALIHERB Shi Shen Tang***Net Wt 3.5 oz (100GM) Chinese Herbal Formula Professional Use Only*** PRODUCT OF TAIWAN***INGREDEINTS:***MFG. NO. CP010217". Recall # F-0375-2012;
 
2) "Shen Mi Tang Mahuang & Magnolia Combination"; Barcode on label: N/A Item # 21022; Mfg No. CP11022, Use By: 12/2013 Inventory on Hand: 1 x 100g unlabeled white, plastic bottle. Product is packaged in a white, plastic bottles with a white affixed label with black, red, and blue printing that reads from left to right, "DIRECTIONS: Take 2-3 grams three times a day***20217***QUALIHERB Shen Mi Tang*** Mahuang & Magnolia Combination Net Wt 3.5 oz (100GM) Chinese Herbal Formula Professional Use Only***SHENG CHANG PHARMACEUTICAL CO., LTD. PRODUCT OF TAIWAN***INGREDEINTS:***MFG. NO. CP011022 ". Recall # F-0376-2012;
 
3) "Ding Chuan Tang Cudraniae & Ginko Combination"; Item # 20802; Mfg No. 2008-12, 100grams. Inventory on Hand: 9 x 100 caps unlabeled bottles, 21 x 100 g labeled bottles Product is packaged in a white, plastic bottles with a white affixed label with black, red, and blue printing that reads from left to right, "DIRECTIONS: Take 2-3 grams three times a day***20802***QUALIHERB Ding Chuan Tang*** Cudraniae & Gingko Combination Net Wt 3.5 oz (100GM) Chinese Herbal Formula Professional Use Only*** PRODUCT OF TAIWAN***. Recall # F-0377-2012
CODE
1) Use By Date: 12/2013;
2) Use By Date: 12/2013;
3) Use By Date: 12/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Finemost Corp., Artesia, CA, by letter and press release on July 28, 2011. 
Manufacturer: Sheng Chang Pharmaceutical Co., Ltd., Taipei, Taiwan. FDA initiated recall is ongoing.
REASON
Product may contain the presence of ephedrine alkaloids.
VOLUME OF PRODUCT IN COMMERCE
94 x 100 g bottles
DISTRIBUTION
CA, CO, VA, WA, MA
___________________________________
PRODUCT
Smoked Split Herring in bulk (no label available). The product was sold loose on a tray. Recall # F-0380-2012
CODE
uncoded
RECALLING FIRM/MANUFACTURER
World Wide Fish Market Inc., Bronx, NY, by press release on September 21, 2011. New York initiated recall is complete.
REASON
The product was discovered to be uneviscerated based on sampling and analysis by New York State Dept. of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
290 boxes
DISTRIBUTION
New York City
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) "***ProMex Sabor Cereza B Doce Supension para Ninos, Vitamina B-12 es esencial para la formacion normal de la Sangre 8 fl. oz. (237 ml)***Other Ingredients: Corn syrup, methylparaben, prophylparaben, sodium, benzoate, citric acid, potassium sorbate, proylene glycol, glyceine, flavor & purified water.***" UPC 1 81425 00002 9. Recall # F-0074-2012;
 
2) " ***CALCIGENOLITO Doble Para Ninos / Kids Doble Con Calcio y Vitamina D los Huesos CREECEN***DIETARY SUPPLEMENT 8 fl oz (237 ml) ***Ingredient (mg/1 oz) Tri-calcium Phosphate 150 mg***Vitamin D 220 IU***L-Lysine 5 mg***Based on 2000 calorie diet***Other Ingredients: Methyl Paraben, Sodium Benzoate, Citric Acid, Potassium Sorbate, Nitrate Propylene Glycol, Glyceine, Xantan gum, Flavor aqua & Sweetener.***” UPC 1 84125 00115 6. Recall # F-0075-2012;
 
3) ProMex, Vitamina B-12, 8 fl oz. (237 ml). "***ProMex Sabor Menta B Doce Supension Adulto Vitamina B-12 es esencial para la formacion normal de la Sangre 8 fl. oz. (237 ml)***Total Calories 28***Total Fat 0 g Sodium 10 mg Total Carbohydrate 4 g Sugars 4 g Protein 0 g***Thiamine HCL (B1) 0.200 g Riboflavin (B 2) 0.291 g Niacin (B 3) as Rutin 1.429 g Pyridoxine HCL (B 6) Cyanocobatamin (B 12) Pantothotenic Acid 1.429 g Ascorbic Acid (Vit C) 96.457 g Inositol 0.02 mg***Other Ingredients: Corn syrup, methyparaben, prolene gloycol, glceine, flavors, purified water, natural & artifical color, potassuim sorbate, sodium benzoate.***" UPC 1 84125 00001 2. Recall # F-0076-2012;
 
4) ProMex, ApetiMex, DIETARY SUPPLEMENT, 8 fl oz (237 ML). "***ProMex ApetiMex DIETARY SUPPLEMENT 8 fl. oz*** Alfalfa & Licorice 30 mg***Vitamin A Palmitate 2250 IU***Vitamin D3 (Cholecalciphenol) 400 IU***Vitamin B1 (Thiamine Mononitate) 1.5 mg***Vitamin B2 (Riboflavin) 1.7 mg***Vitamin B6 (Pyridoxine HCL) 2 mg***Vitamin B12 (Cyanocobalamin) 7mcg***Vitamin B3 Niacin) 5mg***Vitamin B5 (Dicalcium Pantothenate) 3mg***Manganese Sulfate 500mcg***ZincLadate 1200mcg***OTHER INGREDIENTS: Natural & artificial flavor, rosemary extract, methyl & propylparaben, citric acid, sodium benzoate, potassium sorta, propylene glycol and purified water.***" UPC 1 84125 00007 4. Recall # F-0077-2012;
 
5) Tarmac Natural, Shark Cartilage, 750 mg, 50 Capsules."*** Tarmac Natural Shark Cartilage Cartilogo de Tiburon 750 mg * Helps control the degenerative process and aging * Ayuda a controlar los procesos degenerativos y de envejecimiento***Datos del Supplemento Tamano Por Dosis 1 Capsula Dosis Por Envase 50***Cantidad por Dosis***Cartilago de Tiburon 750 mg***Otros Inredientes: celulosa microcristalino, estearato de magnesio y gelatina (de la capsula).***” UPC 7 26576 81101 6. Recall # F-0078-2012;
 
6) Tarmac Natural Calcio 500 mg."***Tarmac Natural Calcio 500 mg. *Natural Source of Calcium *Fuente Natural de Calcio Dosis: Tomar una (1) tableta dos o tres veces al dia, preferiblemente en las comidas. Directtions: Take one (1) tablet twice or three times a day, preferably with meals. 50 TABLETAS***Datos del Suplemento Tamano Por Dosis 1 Tableta Dosis Por Envase 50***Cantidad/Tableta***Calcio 500 ,g ***Othros Ingredientes: celulosa microcristalina, estearato de magnesio, crosprovidone y color.***” UPC 7 26576 17501 9. Recall # F-0079-2012;
 
7) Tarmac Natural, COD LIVER OIL, 50 SOFTGELS. "***Tarmac Natural COD LIVER OIL ACEITE DE HIGADO DE BACALAO * A nutritional supplement rich in natural vitamins A & D. *Un suplemento nutricional rico en vitaminas A & D. 50 SOFTGELS. ***Datos del Suplemento Tamano Por Dosis 1 Softgel Dosis Por Envase 50***Cantidad por Dosis***Calorias 5 Calorias de las grasas 5 Grasa Total 0.5g*** Vitamina A (del Aceite de higado de Bacalao) 1,250 UI***Vitamina D (del Aceite de higado de Bacalao) 135 UI***Otros Ingredientes: gelatina, glicerina, aqua purificada.***” UPC 7 26576 04801 6. Recall # F-0080-2012;
 
8) Tarmac Natural, VITAMIN E, 400 U.I., 50 Capsulas. "*** Tarmac Natural VITAMIN E VITAMINA E 400 U.I. Antioxidant* Antioxidante* 50 Capsulas.***Datos del Suplemento Tamano Por Dosis 1 capsula Dosis Por Envase 50***Cantidad por Dosis***Vitamina E 400 U.I.***dl-Alfa Acetato de Tocoferil***Otros Ingredientes: aceite de soya, gelatina, glicerina y agua purificada ***.” UPC 7 26576 05801 5. Recall # F-0081-2012;
 
9) Tarmac Natural, CAT'S CLAW, UNA DE GATO, 350 mg., 50 Capsulas."***Tarmac Natural CAT'S CLAW UNA DE GATO 350 mg. *Enhances the Immune System*Estimula el Sistema Inmunologico 50 Capsulas***Other Ingredients: Suero, Geletina y Estearato de magnesio.***Directions: Adults, take (1 or 2) capsules daily, preferably with meals.***". UPC 7 26576 91101 3. Recall # F-0082-2012;
 
10) Tarmac Natural, MELATONIN 3 mg., 50 TABLETAS. "***Tarmac Natural MELATONIN MELATONINA 3 mg.*Helps promote sleep*Ayuda a reconciliar el sueno 50 TABLETAS.***Datos del Suplemento Tamano Por Dosis 1 Tableta dosis Por Envase 50***Cantidad por Dosis Melatonia 3 mg.***Otros Ingredientes: acido estearico, almidon, celulosa microcristalina, estearafo de mangnesio y fosfato dicalcio.*** Directions: Adults, take one (1) or two (2) tablets at bedtime.***” UPC 7 26576 07101 4. Recall # F-0083-2012;
 
11) Tarmac Natural, Brewers Yeast, 486 mg., 50 TABLETAS. "***Tarmac Natural Brewers Yeast Levadura de Cerveza 486 mg. *Natural Source of Proteins and B-Complex Vitamins * Fuente Natural de Proteinas y Vitaminas del Complejo B 50 Tabletas ***Otros Ingredientes: acido estearico, estearato de magnesio.***Directions: Adults, take two (2) tablets 3 times daily.***” UPC 7 26576 03101 8. Recall # F-0084-2012;
 
12) Tarmac Natural, Ginseng, 520 mg., 50 CAPS. "***Tarmac Natural Ginseng 520 mg. Helps your body adjust to physical and mental stress. Ayuda su cuerpo a ajustarse a demandas fisicas y mentales de la lension diaria Two (2) capsules daily durring meals. Dos (2) capsuas al dia durante les comidas. 50 CAPS***Other Ingrediants: Magnesium Sterate, Gelatin*** Made in U.S.A.***” UPC 7 26576 61101 2. Recall # F-0085-2012;
 
13) Bedoce PLUS, Multivitamin, B Complex with Folic Acid & Iron, 30 Capsulas. "*** Bedoce PLUS Dietary Supplement 30 Capuls Multivitamin B Complex with Folic Acid & Iron PROMEX***Fight Fatigue***Supplement Facts Serving Size: 1 Capsule Serving Size per Container: 30 capsules % DV Folic Acid 5mg 1250.00% Iron 5mg ** Calcium Ascorbate (Equivalent to Vitamin C) 100mg 166.67% Thiamine Moonitrate (Vitamin B-1) 36mg 2400.00% Riboflavin (Vitamin B-2) 5mg 294-12% Pyridoxine Hydrochloride (Vitamin B-6) 10mg 500.00% Cyanocobalamin (Vitamin B-12) 18 mg 300.00% Inositol 5 mg ***Use: Adults 18 yrs or older 1 tablet daily with food. Not formulated for use in children. Warnings: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. ***” UPC 1 84125 00049 4. Recall # F-0086-2012;
 
14) ArthryDol, Support for Healthy Joints, Pro Mex, 30 Tablets. "***ArthryDol Support for Healthy Joints 30 Tablets DIETARY SUPPLEMENT***ProMEX***Supplemental Facts Serving Size: 2 Tablets Servings Per Container: 30 Calories Total : 15 Amount per Serving Ingredients: Glucosamine 1200mg Chondroitin 1000mg* Methylsulfonylmethane (MSM) 500 mg* Collagen 600mg* Gelatin from Hydrolyzed % Daily Value not Established.***Directions: Suggested Use: For best results, Take 2 tablets daily with a meal. Take for 4 to 6 weeks. Keep bottle tightly closed. Store in a cool, dry place, avoid heat.***” UPC 1 84125 00045 6. Recall # F-0087-2012;
 
15) Adelgadina, Natural, 60 Tablets, Dietary Supplement and diet plan. "***Adelgadina NATURAL 60 Tablets NEW Drug free Caffeine free Sugar free Dietary Supplement and diet plan TARMAC PRODUCTS ***Supplement Facts Serving Size: 1 tablet Servings Per Container 60 *** *Chromium (Nicotinate 250 mcg. 208 Vanadium (Amino Acid Chelate) 100 mcg. * Bitter Orange (6%) 120 mg. * Thermonutrient Blend 100 mg. Ataclyodes Rhizome, Balloon Flower Root, Don Quai Root, Field mint leaf, Forsythia Fruit, Gardenia Fruit, Ginger Root, Licorice Root, Lovage Root, Mirabilite, Schizonepeta Tenufolia Stem, Siler Root, Skullcap Root, Steatitle Terra alba, White Peony Root * Daily Value not established Other Ingredients: Dicalcium Phosphate Microcrystaline Cellulose, Stearic Acid, Croscarmellose Sodium, Hydroxypropyl Methyl Cellulose, Magnesium Stearate, Magnesium Silicate, polyethylene Glycol and Mineral Oil.***DIRECTIONS: Take one tablet 1 to 3 times daily, before or with meals***Made in U.S.A.***" UPC 7 26576 18101 0. Recall # F-0088-2012;
 
16) AMOXIMIEL, Probiotic, 600 mg, 30 Capsules, Natural Alternative without side affects. "***AMOXIMIEL Probiotic 600 mg 30 Capsules Natural Alternative without side effects***PRO-MEX Dietary Supplement***Supplement Facts Serving Size: 2 capsules Serving Size per Container; 30 capsules DV% Wild Mediterranean Oregano 20mg * Bee Pollen Powder 100mg * Golden Seal 200mg * Garlic Powder 100 mg * Echinacea Purpureus Herba 350 mg * Myrrh 50mg***Dandelion Root Power 200mg * Gelatin & Stearic acid * * ***Directions: Adults 18 years and over - Take 1 tablet 2 times a day with meals. Take it continuously for 15 days for better results. Children Ask a doctor***Pro-Mex.***” UPC 1 84125 00102 6. Recall # F-0089-201;
 
17) CALCIGENOL Doble/ Concentrate SUSPENSION DIETARY SUPPLEMENT 8 fl oz (240 ml). "*** CALAIGENOL double/ Concentrate SUPSPENSION CALCIO Y FOSFORO***Con Calcio y Fosforo los Huesos CREEECEN!!!***DIETARY SUPPLEMENT 8 fl oz (240 ml)***Supplement Facts Serving Size: 2 tablespoonful (30ml) Servings per Container: About 32***Active Ingredient (mg/30ml) Vitamin D 400IU***Vitamin C 60mg***Coral Calcium 25mg***Calcium Glycerophosphate 500mg*** L-Lysine 10mg***Other Ingredients: Corn Syrup,Methyl Paraben, Prophyl Paraban, Sodium Benzoate, Citric Acid, Potassium Sorbate, Propylene Glycol, Glycerine, Sucrolose, Citrus Flavor, and Purified Water.***DIRECTIONS: Adults: take a tablespoonful (30ml) every morning with meals Children after 12 yrs old: 1 teaspoon 2 times a day with meals.***” UPC 1 84125 00017 3. Recall # F-0090-2012;
 
18) "***PRO-MEX***Ampitrexyl 500 mg 30 Capsules / Capsulas***Suggested Use: As a dietary supplement for adults. Keep out of reach of children. Do no use if safety seal is broken if pregnant or breastfeeding, do not use this product. If you have a medical condition or take medication regularly, consult your physician before use.***Other Information: Store between 59-86F (16-30C)***Supplement Facts Serving Size: 2 capsules Servings per Container 15***Amount per Serving Andrographitis Extract 450 mg***Corydails Yanhusuo 50 mg***Other Ingredients: burdoc root, microcrystalline cellulose, spleen, bee propolis, echuneacea extract, garlic extract.***". UPC 1 84125 00043 2. Recall # F-0091-2012;
 
19) Product is labeled in part: "***ProMex***Super Bedoce***30 tablets***Dietary Supplement Serving Size: 1 tablet*** Servings per Container: 30***Amount per Serving***Calcium Ascorbate (Equivalent to Vitamin C) 100MG***Folic Acid 5mg***Thiamine Mononitrate (Vitamin B-1) 36mg***Riboflavin (Vitamin B-2) 5mg***Pyridoxine Hydrochloride (Vitamin B-6) 10mg***Cyanocobalamin (Vitamin B-12) 18mg***Inositol 5mg***Rulin 5mg***Other Ingredients: Microcrystalline Cellulose, sodium Crosscamellose, dicalcium Phosphate, Stearic Acid and Magnesium.***" UPC 1 84125 00013. Recall # F-0092-2012;
 
20) Product is labeled in part: "***ProMex***Bedoce For Children***30 Tablets***Dietary Supplement Serving Size: 1 Tablet*** Servings per Container: 30***Amount per Serving***Vitamin A 2500 IU***Vitamin C 250mg***Vitamin D 400 IU***Vitamin E 15 IU***Thiamin (B1) 1.05 mg***Riboflavin (B2) 1.2 mg***Niacin (B3) 13.5 mg***Vitamin B6 1.05 mg***Folate, Folic Acid, Folacin 300mcg***Vitamin B12 4.5 mcg***Other Ingredients: Microcrystalline Cellulose, Sodium Crosscamellose, Dicalcium Phosphate, Stearic Acid and Magnesium Stearate.***INDICATIONS: For the deficiency of the vitamin of the formula***". UPC 1 84125 00006 7. Recall # F-0093-2012;
 
21) No product labeling is available: "***Bronco Limpio Jarbe, 8oz***". Recall # F-0094-2012
CODE
All Lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals, Hialeah, FL, by letter on July 26, 2011 and by e-mail or telephone between June 1, 2011 and July 26, 2011.
Manufacturers: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals, Hialeah, FL;
Promex, LLC, Hialeah, FL;
Natural Vitamins Laboratory, Opa Locka,  FL.
FDA initiated recall is ongoing.
REASON
Products were not manufactured under cGMP's and were stored in uncontrolled temperature and humidity conditions.
VOLUME OF PRODUCT IN COMMERCE
255,177 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) "***TRIGAL***Empanadillas Sabor a Carne (Meat flavored turnovers) ***12 ct***". Recall # F-0108-2012;
 
2) "***TRIGAL***Plantillas Coctel para Pastelillos y Tacos (turnovers and tacos dough rounds) ***12 ct, 20 ct, 24 ct. ***" Recall # F-0111-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Pastry Food Products Inc., San Juan, PR, by letter on August 29, 2011. FDA initiated recall is ongoing.
REASON
Undeclared soy oil declared as "vegetable oil".
VOLUME OF PRODUCT IN COMMERCE
1) 30 boxes (12 ct); 2) 6 boxes (24 ct)
DISTRIBUTION
PR
___________________________________
PRODUCT
Kalona Supernatural, Organic Whole Milk, Cream Top, packaged in 1-gal. and 1/2 gallon plastic containers, packaged 64 oz/half gallon - 6 containers/case and 128 oz/gallon-4 containers/case. Recall # F-0135-2012;
CODE
Sell by date: 10/22/11
RECALLING FIRM/MANUFACTURER
Farmers' All Natural Creamery LLC, Wellman, IA, by telephone on October 6, 2011. Iowa initiated recall is ongoing.
REASON
The milk tested positive for residual phosphatase.
VOLUME OF PRODUCT IN COMMERCE
954 gallons (1884/half-gallon containers and 12/one gallon containers)
DISTRIBUTION
IL. CO, TX
___________________________________
PRODUCT
"SV BAKED SOY BEAN CAKE 10 oz (283g) ***". UPC 08790470166 0. Recall # F-0143-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Visoy Food, Inc., Los Angeles, CA, via hand deliver letter on October 28, 2011. FDA initiated recall is ongoing.
REASON
The recall was initiated because Visoy Food has confirmed that the bake soy bean cake contains undeclared wheat as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
26,000 packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Chevre Plain Cheese made from pasteurized goat milk. Product is packaged in plastic tub; net weight is 6 ounces. In addition it was distributed in a 25 lb. bucket and 2 lb. sealed bags. The product is labeled in part, "Fraga Farm Goat Cheese***Chevre Plain - Organic Pasteurized Goats Milk, Culture, Vegetable Rennet, Kosher Salt. ***Net Wt 6 oz***". Recall # F-0146-2012;
 
2) Chevre Chef's Blend made from pasteurized goat milk. Product is packaged in plastic tub; net weight is 6 ounces. The product is labeled in part, "Fraga Farm Goat Cheese***Chevre Chef's Blend - Organic Pasteurized Goats Milk, Culture, Vegetable Rennet, Kosher Salt, Organic Garlic and Organic Spices.***Net Wt 6 oz.***". Recall #F-0147-2012;
 
3) Chevre Greek Olive Cheese made from pasteurized goat milk. Product is packaged in plastic tub; net weight is 6 ounces. The product is labeled in part, "Fraga Farm Goat Cheese***Chevre Greek Olive - Organic Pasteurized Goats Milk, Culture, Vegetable Rennet, Organic Greek Olives, Artichoke Hearts, Citric Acid, Kosher Salt, Organic Olive Oil, Organic Garlic, Organic Herbs, Spices.***Net Wt 6oz.***". Recall # F-0148-2012;
 
4) Goat'zarella made from pasteurized goat milk. Product is packaged in 5 - 7 ounce vacuum packed bags and 6 - 8 pound vacuum packed bags (whole wheels). The product is labeled in part, "Fraga Farm Goat Cheese***Goat'zarella Ingredients: Organic Pasteurized Goats Milk, Culture, Vegetable Rennet, Kosher Salt. ***Net Wt 5-7 oz***". Recall # F-0149-2012
CODE
1) #129 exp10-1-11;
2) #129 exp 10-1-11;
3) #129 exp 10-1-11;
4) #128 exp 10-14-11
RECALLING FIRM/MANUFACTURER
Fraga Farm Goat Cheese LLC, Sweet Home, OR, by telephone on September 29, 2011. Oregon initiated recall is ongoing.
REASON
Product was not adequately processed and has the potential to be contaminated with Listeria and/or Salmonella.
VOLUME OF PRODUCT IN COMMERCE
76 lbs
DISTRIBUTION
OR
___________________________________
PRODUCT
These edible logos are chocolate decorations (white and dark) and is a novelty item made to order; therefore, the product description varies per customer order. The product is packaged in a 10 X 13 X 2" box. The edible logos are multi-colored and vary in size between 3/4 inch to 4 inches. An example of a label on an outer case reads as follows: "Net Wt. 2.13 Lbs / 960 Grams***Item #: DH 800 (1" Round) Ct:560***Ingred: May contain sugar, cocoa mass, cocoa butter, whole milk powder, skimmed milk powder, emulsifier (lecithin), vanilla extract. Partially hydrogenated palm kernel oil & lecithin. FD&C Yellow#5&6, Titanium Dioxide, Red# 40, Blue# 1&2***." Recall # F-0164-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Sweet Swiss Confections, Inc., Spokane, WA, by e-mail on November 7, 2011. FDA initiated recall is ongoing.
REASON
The firm uses and declared lecithin on the ingredient statement; however, the label does not list lecithin as "soy" lecithin.
VOLUME OF PRODUCT IN COMMERCE
approximately 1,201,434 pieces in various sizes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Trader Joe's English Toffee candy, SKU 48303. Labeling reads in part:"***TRADER JOE'S English Toffee with Milk Chocolate NET WT. 8 OZ (227g)". Recall # F-0293-2012
CODE
All codes. (sell by dates July 7, 2012 to August 30, 2012).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trader Joes Co, Monrovia CA, by letter on October 20th, 2011.
Manufacturer: Bazzini Holdings L.L.C, Allentown PA. Firm initiated recall is ongoing.                                 
REASON
This recall was initiated by the firm due to a report of two very small glass fragments discovered in a related product manufactured at the firm's contract manufacturer.
VOLUME OF PRODUCT IN COMMERCE
11,907 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Azuki Bean Ice Cream, Item #163. Recall # F-0294-2012;
2) Banana Ice Cream, Item #112. Recall # F-0295-2012;
3) Black Sesame Ice Cream, Item #116. Recall # F-0296-2012;
4) Cappuccino Ice Cream, Item #120. Recall # F-0297-2012;
5) Caramel Ice Cream, Item #115. Recall # F-0298-2012;
6) Caramel Swirl Ice Cream, Item #117. Recall # F-0299-2012;
7) Dutch Chocolate Ice Cream, Item #109. Recall # F-0300-2012;
8) Espresso Chip Ice Cream, Item #119. Recall # F-0301-2012;
9) Espresso Ice Cream, Item #118. Recall # F-0302-2012;
10) French Vanilla Ice Cream, Item #134. Recall # F-0303-2012; 
11) Ginger Ice Cream, Item #131. Recall # F-0304-2012;
12) Grand Marnier Ice Cream, Item #139. Recall # F-0305-2012; 
13) Green Tea Ice Cream, Item #132. Recall # F-0306-2012;
14) Lavender Ice Cream, Item #130. Recall # F-0307-2012;
15) Lemon Verbena Ice Cream, Item #187. Recall # F-0308-2012;
16) Mascarpone Ice cream, Item #125. Recall # F-0309-2012;
17) Mint Belgium Chocolate Ice cream, Item #113. Recall # F-0310-2012;
18) Root Beer Ice cream, Item #191. Recall # F-0311-2012;
19) Rum Raisin Ice cream, Item #133. Recall # F-0312-2012;
20) Strawberry Ice cream, Item #104. Recall # F-0313-2012;
21) Tiramisu Ice cream, Item #110. Recall # F-0314-2012;
22) Vanilla Bean Ice cream, Item #100.Recall # F-0315-2012;
23) Vanilla Supreme Ice cream, Item #185.Recall # F-0316-2012;
24) White Chocolate Raspberry Ice cream, Item #103.Recall # F-0317-2012;
25) Blueberry Ice cream, Item #148. Recall # F-0318-2012;
26) Bourbon Ice cream, Item #155. Recall # F-0319-2012;
27) Chocolate Malt Ice cream, Item #172. Recall # F-0320-2012;
28) Strawberry Malt Ice cream, Item #171. Recall # F-0321-2012;
29) Egg Nog Gelato, Item #840. Recall # F-0322-2012;
30) Extra Virgin Olive Oil Gelato, Item #871. Recall # F-0323-2012;
31) Pumpkin Gelato, Item #824. Recall # F-0324-2012;
32) Carrot Gelato, Item #899. Recall # F-0325-2012;
33) Chocolate Gelato, Item #809. Recall # F-0326-2012;
34) Cinnamon Gelato, Item #823. Recall # F-0327-2012;
35) Double Chocolate Gelato, Item #810. Recall # F-0328-2012;
36) Espresso Gelato, Item #819. Recall # F-0329-2012;
37) Vanilla Gelato, Item #800. Recall # F-0330-2012;
38) Banana Walnut Ice cream, Item #107. Recall # F-0331-2012;
39) Butter Pecan Ice cream, Item #150. Recall # F-0332-2012;
40) Cappuccino Crunch (almond) Ice cream, Item #137. Recall # F-0333-2012;
41) Caramel Pecan Ice cream, Item #121. Recall # F-0334-2012;
42) Coconut Ice cream, Item #108. Recall # F-0335-2012;
43) Maple Walnut Ice cream, Item #174. Recall # F-0336-2012;
44) Caramel Praline Ice cream, Item #126. Recall # F-0337-2012;
45) Honey Almond Ice cream, Item #178.Recall # F-0338-2012;
46) Coconut Gelato, Item #808. Recall # F-0339-2012;
47) Gianduia Gelato, Item #814. Recall # F-0340-2012;
48) Hazelnut Gelato, Item #817. Recall # F-0341-2012;
49) Toasted Almond Gelato, Item #894. Recall # F-0342-2012;
50) Sicilian Pistachio Gelato, Item #816. Recall # F-0343-2012;
51) Coconut Sorbet, Item #239. Recall # F-0344-2012;
52) Peanut Butter Gelato, Item #815. Recall # F-0345-2012;
53) Mascarpone Lemon Sorbet, Item #299. Recall # F-0346-2012;
54) Lemon Sorbet, Item #200. Recall # F-0347-2012;
55) White Chocolate Ice Cream, Item #122. Recall # F-0348-2012;
56) Cinnamon Ice Cream, Item #123. Recall # F-0349-2012;
57) Orange Creamsicle Ice Cream, Item #153. Recall # F-0350-2012;
58) Grape Ice Cream, Item #157. Recall # F-0351-2012;
59) Vanilla Malt Ice Cream, Item #170. Recall # F-0352-2012;
60) Sour Cream Sorbet, Item #240. Recall # F-0353-2012;
61) Sour Cream Blueberry Sorbet, Item #240. Recall # F-0354-2012
CODE
1) Unit: 163062511;
2) Unit: 112114511;
3) Unit: 116104311;
4) Unit: 120092711;
5) Unit: 115104311;
6) Unit: 117104011;
7) Unit: 109114511;
8) Unit: 119114511;
9) Unit: 118114511;
10) Unit: 134104111;
11) Unit: 131104311;
12) Unit: 139114411;
13) Unit: 132114411;
14) Unit: 130093611;
15) Unit: 187104011;
16) Unit: 125114511;
17) Unit: 113114511;
18) Unit: 191114511;
19) Unit: 133104011;
20) Unit: 104104311;
21) Unit: 110104111;
22) Unit: 100114511;
23) Units: 185093811, 185093911, 185104011, 185104111, 185104211, 185104211, 185104311, 185104411, 185114411, 185104511;
24) Unit: 103104211;
25) Unit: 148083111;
26) Unit: 155104111;
27) Unit: 172062511;
28) Unit: 104083311;
29) Unit: 840093611;
30) Unit: 871083211;
31) Unit: 824114511;
32) Unit: 899083111;
33) Units: 809093811, 809104211, 809104311;
34) Unit: 823114511;
35) Unit: 810104211;
36) Unit: 819114411;
37) Unit: 800093811, 800104011, 800104111, 800104211, 800104311, 800104411, 800114511;
38) Unit: 107093711;
39) Unit: 150083211;
40) Unit: 137092711;
41) Unit: 121072811;
42) Unit: 108104011;
43) Unit: 174114111;
44) Unit: 126072811;
45) Unit: 178104311;
46) Unit: 808083111;
47) Unit: 814104011; 
48) Unit: 817083111;
49) Unit: 894114411;
50) Unit: 816114511;
51) Unit: 239083311;
52) Unit: 815114511;
53) Unit: 299062311;
54) Unit: 200114511;
55) Unit: 122093711;
56) Unit: 123104211;
57) Unit: 153104211;
58) Unit: 157083111;
59) Unit: 170083511;
60) Unit: 240104311;
61) Unit: 240104311
RECALLING FIRM/MANUFACTURER
Unique Distributors, Inc., Cypress, CA, by letter on November 11, 2011, FDA initiated recall is ongoing.
REASON
The ice cream, gelato, and sorbet product labeling does not contain an ingredient statement and the products contain undeclared allergens: eggs, milk, soy, and/or tree nuts.
VOLUME OF PRODUCT IN COMMERCE
2081 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Lao Mien, noodles. Noodles containing no eggs. Lao Mien, brand name: A-Farms. Unit size: 1 case contains 8/5lb plastic bags. Noodles are wrapped in plastic bags, which are then placed in a cardboard box. F-0379-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: A Farm Trading Inc., South El Monte, CA, by e-mail letter on September 15, 2011.
Manufacturer: An-Tai Chinese Noodles Inc, South El Monte, CA. FDA initiated recall is ongoing.
REASON
During a routine FDA inspection, it was found that the products being recalled, labels do not contain an allergen statement for wheat flour as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
18,229 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
Miel Pur Honey Processed by Po Sang Yuen Bee Farm (Hong Kong) Ltd (19.5FL oz.) Packed by Po Sang Yuen Bee Farm Hong Kong Ltd. Wu Tip Shan Road Fanhing NT Hong Kong Nutrition Facts (1 tbsp). Recall # F-0381-2012
CODE
Lot no. 635
RECALLING FIRM/MANUFACTURER
Recalling Firm: Summit Import Corp., Jersey City, NJ, by letters dated July 26, 2011.
Manufacturer: Po Sang Yuen Bee Farm Hk Ltd, Fanling, Hong Kong SAR. New York initiated recall is ongoing.
REASON
NYSDAM results reveal the presence of ciprofloxacin in honey.
VOLUME OF PRODUCT IN COMMERCE
25 cartons (12 bottles in each carton)
DISTRIBUTION
NY, PA, FL, OH
___________________________________
PRODUCT
Subway Light Tuna Net Wt. 2 lbs 11 oz. (1.22 kg) Pouch Code Product of Philippines.
Recall # F-0382-2012
CODE
SES2 GU1611 Best Before: JUN 10 13
RECALLING FIRM/MANUFACTURER
Rema Foods Inc., Englewood Cliffs, NJ,  by telephone on November 8, 2011 and letter on November 9, 2011. FDA initiated recall is ongoing.
REASON
One lot of Subway Light Tuna contains elevated levels of histamine discovered through FDA Sampling.
VOLUME OF PRODUCT IN COMMERCE
2345 cases
DISTRIBUTION
FL, NE, PA
___________________________________
PRODUCT
Soy Jello (soft tofu) in 16 oz. plastic container, store refrigerated. Recall # F-0385-2012
CODE
All products produced prior to 9/26/2011.
RECALLING FIRM/MANUFACTURER
Wa Heng Dou Fu Soy Sauce Corp., Sacramento, CA, by visit, beginning October 21, 2012. FDA initiated recall is ongoing.
REASON
Positive findings of Salmonella Havana were found in environmental swabs of food contact surfaces.
VOLUME OF PRODUCT IN COMMERCE
60-80 cups per week
DISTRIBUTION
CA
___________________________________
PRODUCT
Ocean Spray Original Flavor Craisins- Dried Cranberries packaged in: a) 5 oz, UPC: 00293-000; b) 10 0z, UPC: 29456-000 and 29464-000; c) 48 oz, UPC: 00678-318; and d) 10 lb bulk ingredient & foodservice, UPC: 03477-000. Expanded recall 12/2/11: Ocean Spray Original Flavor Craisins Dried Cranberries are added to this recall: e) 5 oz Craisins UPC: 00293-000; f)10 oz Craisins, UPC: 29456-000 and 29464-000; g) 48 oz Craisins, UPC: 00678-318. Recall # F-0389-2012 
CODE
a) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): Oct 27 2012 M;
b) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): Oct 27 2012 M Oct 28 2012 M Oct 29 2012 M;
c) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): Oct 27 2012 M Oct 28 2012 M Nov 3 2012 M Nov 4 2012 M Nov 5 2012 M Nov 6 2012 M Nov 7 2012 M Nov 10 2012 M Nov 11 2012 M;
d) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): 30 Oct 2013 M 31 Oct 2013 M 1 Nov 2013 M 5 Nov 2013 M;
Expanded recall 12/2/11: e) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): Oct 28 2012 M;
f) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED: Oct 30 2012 M;
g) Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER M ARE AFFECTED): Oct 29 2012 M Nov 8 2012 M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ocean Spray Cranberries Inc., Middleboro, MA, by press release and letter on November 25, 2011, and by press release on December 2, 2011.
Manufacturer: Ocean Spray Cranberries Inc., Aberdeen, WA. Firm initiated recall is ongoing.
REASON
Foreign material
VOLUME OF PRODUCT IN COMMERCE
14,290 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
All Natural Charlie's Cheesecake Poppers, All Natural Real California Cream Cheese, box of 35 count - 7 assorted flavors, 1 oz Bite-size cheesecakes; Flavors vary but may contain a variety of 12 flavors: Blueberry, Cappuccino, Chocolate, Key Lime, Raspberry, Silicon Valley Classic, Strawberry, Pumpkin, Amaretto, Caramel and Chocolate Chip. Labeling issue only affects chocolate and chocolate chip poppers. Net wt. 35 oz (2 lbs 2 oz). Keep frozen. Recall # F-0390-2012
CODE
lot date code of 110531 and earlier
RECALLING FIRM/MANUFACTURER
McMajor Enterprises, Inc., dba Charlie's Cheesecake Works, San Jose, CA, by letter on November 30, 2011. FDA initiated recall is ongoing.
REASON
FDA inspection found that Chocolate and Chocolate Chip Poppers did not declare soya lecithin in the ingredient labeling.
VOLUME OF PRODUCT IN COMMERCE
15 cases of 105 count, 38 boxes of 35 count
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Tiger's Milk nutrition bar, Peanut Butter and Honey flavor, 1.23 oz. bars, packaged in Club Packs with Peanut Butter flavor and Protein Rich flavor bars. UPC 020525516916. Recall #F-0165-2012
CODE
Lot #A2231A, sub lots BF, BF, BH, and BI.5,671 bars (on bars) Lot #K2371A2, K2411A2, K2431A2 and K2501E2 (on carton)
RECALLING FIRM/MANUFACTURER
Schiff Nutrition International, Inc., Salt Lake City, UT, by fax and telephone on November 4, 2011.  Firm initiated recall is ongoing.
REASON
Nutrition bars may be contaminated with residual sanitizing solution used on the equipment.
VOLUME OF PRODUCT IN COMMERCE
5,671 bars
DISTRIBUTION
AZ, CA, CO, HI, NM, NV
___________________________________
PRODUCT
Wegmans Sweet Mashed Potatoes, 24 ounce (1 LB 8 OZ) 680 grams, sealed plastic tray with wrap-around sleeve, UPC Code 77890 22978. Recall # F-0378-2012
CODE
Use by: NOV 18 11 DSA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orval Kent Food Company, Inc., Wheeling, IL, by letter on November 10, 2011.
Manufacturer: Orval Kent Food Company Inc., Delphos, OH. Firm initiated recall is ongoing.
REASON
The firm received complaints of white brittle plastic in the product.
VOLUME OF PRODUCT IN COMMERCE
443 cs/6/24 oz trays
DISTRIBUTION
NY
___________________________________
PRODUCT
1) TCBY Frozen Yogurt Layer Cake --- Vanilla Yogurt with White Cake --- Net wt 44 oz (1.24 kg) KEEP FROZEN. Product Code 02783, UPC 04900027838. Recall # F-0383-2012;
 
2) TCBY Frozen Yogurt Layer Cake, Vanilla Fudge Swirl Yogurt with Chocolate Cake, KEEP FROZEN --- Sizes: 44 oz (1.24 kg), UPC 04900027855, product code 02785; 88 oz (2.49kg) UPC 04900027862, product code 02786. Recall # F-0384-2012
CODE
none
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo, NY, by letter on March 15, 2011.
Manufacturer: Rich Products Corp., Santa Fe Springs, CA. Firm initiated recall is ongoing.
REASON
Rich Products Corp. has determined that a small number of cases of TCBY Frozen Yogurt Layer Cakes are misbranded because they do not declare a food coloring additive used to make the products. Specifically, the ingredient statement on the individual package labels do not declare the food coloring additive FD&C Red 40.
VOLUME OF PRODUCT IN COMMERCE
5,261 cases
DISTRIBUTION
Nationwide
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALL FIELD CORRECTIONS
October 19, 2011 posting
87) ITRACONAZOLE, 100 MG, Caplets, NDC 00185-0550-30 should be ISRADIPINE 5 MG TABLET, NDC 00173-0784-01 AND Lot# 10102915, Exp. 02/02/12. Recall # D-312-2012
 
October 26, 2011 posting
58) ZINC SULFATE, 220 MG, TABLET, NDC 57896-0865-01, Lot 865N03, Exp. 08/24/11, 11/19/11 should be ZINC SULFATE, 25MG, TABLET, NDC 00394-0124-02 AND Lot# 59001, Exp. 05/17/12. Recall # D-374-2012
 
60) ZOLPIDEM TARTRATE, 10 MG, TABLET, NDC 00378-5310-01 should be ZINC SULFATE, 220 MG, Capsules, NDC: 00904-5332-60, 60258-0131-01, 68585-0008-01 AND Lot# 32398, Exp 11/30/11; 32761 Exp 12/14/11, 01/17/12; 33575 Exp 02/08/12, 02/11/12, 02/16/12, 02/21/12, 02/28/12, 03/01/12, 03/14/12; 33576 Exp 03/28/12, 05/09/12, 05/15/12; 24928402 Exp 05/27/11; 26580403 Exp 07/07/11; 33466 Exp 03/01/12; 586548 Exp 11/17/11; 5864-47 Exp 10/28/11; 5865-48 Exp 12/15/11; 5865-50 Exp 03/29/12. Recall # D-376-2012;
 
November 2, 2011 Posting
12) Acetaminophen, 325 MG, Tablets, NDC 00536-3222-01, 00603-0263-32, 00904-1982-80, 50580-0501-80, 51645-0703-10. Recall # D-1013-2012; should be D-1013-2011.
 
November 9, 2011 Posting
29) Thioridazine HCL, 10 MG, Tablet, NDC 53489-0148-01 should be THIORIDAZINE HCL 25 MG TABLET, NDC 53489-0149-01 AND Lot# 63191, Exp 09/01/11. Recall # D-748-2012
 
RECALLS PENDING CLASSIFICATION: DRUGS
­­
No Early Posting Notifications this week
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Lactated Ringer's Injection, USP, 1000 mL VisIV Flexible Container, Rx only; NDC 0409-7953-48; barcode (01)00304097953486. Recall # D-874-2012
CODE
Lot #: 07-079-JT, Exp 01 JUL 2013; 08-162-JT, Exp 01 AUG 2013
RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IL, by letter on November 14, 2011 and website posting on November 15, 2011.
Manufacturer: Hospira, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The product has the potential for channel leak at the seal of the fill tube to the bag (mandrel seal) which can result in an open system and potential for contamination and compromised sterility.
VOLUME OF PRODUCT IN COMMERCE
210,924 containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Etodolac Extended Release Tablets, USP, 600 mg, 100-count tablets per bottle; Rx only, NDC 60429-315-01. Recall # D-887-2012;
 
2) Etodolac Extended Release Tablets, USP, 500 mg, 100-count tablets per bottle, Rx only, NDC 60429-314-01. Recall #: D-888-2012;
 
3) Etodolac Extended Release Tablets, USP, 400 mg, 100-count tablets per bottle, Rx only, NDC 60429-313-01. Recall # D-889-2012;
 
4) Etodolac Tablets, USP, 500 mg, 100-count tablets per bottle, Rx only, NDC 60429-312-01. D-890-2012;
 
5) Etodolac Tablets, USP, 400 mg, 100-count tablets per bottle, Rx only, NDC 60429-311-01. Recall # D-891-2012; 
 
6) Etodolac Capsule, USP, 300 mg, 100-count capsules per bottle, Rx only, NDC 60429-244-01. Recall # D-892-2012;
 
7) Etodolac Capsule, USP, 200 mg, 100-count capsules per bottle, Rx only, NDC 60429-243-01. Recall # D-893-2012
CODE
1) Lot #: 119395A, Exp 05/14;
2) Lot #: 119385A, Exp 03/13;
3) Lot #: 107981A, 107981B, Exp 10/13; 106754A, Exp 11/13;
4) Lot #: 118712B, Exp 01/14;
5) Lot # 119660A, Exp 05/14;
6) Lot # 119086A, Exp 02/14;
7) Lot # 119087B, Exp 05/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gsms, Camarillo, CA, by letters on August 31, 2011, September 9, 2011 and December 2, 2011.
Manufacturer: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect or Missing Package Insert: Certain lots of Etodolac Immediate Release tablets were packaged with Etodolac Extended Release inserts.
VOLUME OF PRODUCT IN COMMERCE
10,185 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Omnaris (ciclesonide) Nasal Spray, 50mcg, 12.5 g, 120 Metered Actuations (NDC 63402-701-01), Professional Sample-Not for Sale, 7.1 g, 60 metered actuations (NDC 63402-701-02), For Intranasal Use Only, Rx only. Made in Germany. Recall # D-894-2012
CODE
Lot Numbers: Lot 138305 Exp. Date August 2012 (Retail); Lot 144540 Exp. Date October 2012 (Professional Samples)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunovion Pharmaceuticals, Inc., Marlborough, MA, by letter dated November 28, 2011. 
Manufacturer: Nycomed GmbH (frmly: Altana), Singen (hohentwiel), Germany. Firm initiated recall is ongoing.
REASON
Product lacks stability: Product stability is not assured to expiration.
VOLUME OF PRODUCT IN COMMERCE
66, 045 sprays Lot 138305; 112,980 sprays Lot 144540
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CETIRIZINE HYDROCHLORIDE SYRUP (CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP), FOR ORAL USE ONLY, 1 mg/mL, 120 mL and 480 mL, Rx only, NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL). Recall # D-895-2012
CODE
Lot Numbers: L083A10A, exp. 02/12; L083A10B, exp. 02/12; L006C10A, exp. 03/12; L006C10B, exp. 03/12; L027C10A, exp. 04/12. L133C10A, exp. 04/12; L134C10A, exp. 04/12; L043D10A, exp. 04/12; L044D10A, exp. 06/12; L045D10A, exp. 06/12; L045D10B, exp. 06/12; L046D10B, exp. 06/12; L047D10A, exp. 06/12; L065E10A, exp. 06/12; L066E10A, exp. 06/12; L067E10A, exp. 06/12; L036F10A, exp. 07/12; L037F10A, exp. 07/12, L037F10B, exp. 07/12; L089G10A, exp. 08/12; L089G10B, exp. 08/12; L006H10B, exp. 08/12; L007H10A, exp. 08/12; L008H10A, exp. 08/12; L009H10A, exp. 09/12; L010H10A, exp. 09/12; L011H10A, exp. 10/12; L026H10A, exp. 10/12, L027H10A, exp. 10/12; L028H10A, exp. 10/12; L029H10A, exp. 10/12; L030H10A, exp. 10/12; L019J10A, exp. 10/12; L020J10A, exp. 10/12; L030J10A, exp. 10/12; L031J10A, exp. 10/12; L94J10A, exp. 11/12; L095J10A, exp. 11/12; L070K10A, exp.11/12; L071K10A, exp.11/12; L072K10A, exp. 11/12; L001L10A, exp. 11/12; L044L10A, exp. 12/12; L044L10B, exp. 12/12; L052L10A, exp. 11/12; L053L10A, exp. 11/12; L077L10A, exp. 12/12; L077L10B, exp. 12/12; L082L10A, exp. 01/13; L082L10B, exp. 01/13; L002M10A, exp. 12/12; L003M10A, exp.12/12; L003M10B, exp. 12/12; L012M10A, exp. 12/12; L013M10A, exp. 12/12; L038M10A, exp. 12/12; L022A11A, exp. 02/13; L022A11B, exp. 02/13; L023A11A, exp. 02/13; L023A11B, exp. 02/13; L024A11A, exp. 03/13; L037A11A, exp.03/13; L053A11A, exp. 02/13; L014C11A, exp.02/13; L132C11B, exp. 04/13; L044D11A, exp. 04/13; L063D11A, exp.05/13; L004F11A, exp. 05/13; L005F11A, exp. 05/13; L005F11B, exp. 05/13
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters on November 11, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Failure;18 month time point.
VOLUME OF PRODUCT IN COMMERCE
870,394 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Glyburide Tablets, USP, 5 mg Rx only, 30 count bottle, NDC 54868-3265-1; 2) 60 count bottle, NDC 54868-3265-3, 3) 90 count bottle, NDC 54868-3265-4. Recall # D-896-2012
CODE
Units: 506X, 51MT, 54CE, 55X1, 56Y8, 58XF', 5AA3, 5EAD, 5HYG, 5FTN, 4BSY, 4CD5, 4E01, 4FSS, 4LOZ 4J6N, 4J94, 4OUI, 4XB, 4QMH, 4RX3, 4VGF, 4QMH, 4RX3, 4VGF, 4WIG, 4YNE 4D2P, 417R 4Y4K
RECALLING FIRM/MANUFACTURER
Physicians Total Care, Inc., Tulsa, OK, letter dated April 7, 2011. Firm initiated recall is complete.
REASON
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset.
VOLUME OF PRODUCT IN COMMERCE
189 packages (package size 100 count)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Hydroxyzine Pamoate Capsule, USP, 50 mg, 500-count bottle, NDC 0591-0801-05. Recall # D-875-2012
CODE
Lot #: 3087717, Exp 05/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories Inc., Corona, CA, by letter on November 7, 2011.
Manufacturer: Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
cGMP Deviations: Some capsules were found to have an additional cap over one-half of the capsule body.
VOLUME OF PRODUCT IN COMMERCE
288 Bottles
DISTRIBUTION
MO
___________________________________
PRODUCT
1) Albuterol Sulfate Extended-Release Tablets, 4 mg, 100-count tablets per bottle, Rx only; NDC 68774-400-01. Recall # D-884-2012;
 
2) VoSpire ER (albuterol sulfate) Extended-Release tablets, 4 mg, 6-count tablets per bottle, Rx only; NDC 68774-600-06, Patient Starter Pack. Recall # D-885-2012
CODE
1) Lot #: 7549012, Exp 08/12;
2) Lot # 7549012B, Exp 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: DAVA, Inc., Fort Lee, NJ, by letter on August 3, 2011.
Manufacturer: Pliva, Inc., East Hanover, NJ. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: These lots are being recalled due to a failure on stability test for dissolution at 19-months aging.
VOLUME OF PRODUCT IN COMMERCE
6,378 bottles of 100; 20,308 bottles of 6
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0259-12
CODE
Unit: W141607215922
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile on March 6, 2008. 
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0260-12
CODE
Unit: W141606001764
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by electronic mail on June 5, 2007.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0261-12;
2) Red Blood Cells. Recall # B-0262-12
CODE
1) and 2) Unit: W141608574766
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on October 9, 2008.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 1g size, product code 1500190, NDC# 0944-2700-02. Recall # B-0266-12
CODE
Units: LE12L057AD, LE12L057AE, LE12L071AB, E12L126AB, LE12L133AC, LE12L199AB 
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Lessines, Belgium, by letter on October 26, 2011 and October 28, 2011. Firm initiated recall is ongoing.
REASON
GAMMAGARD LIQUID, possibly containing metallic particles partially embedded in the glass on the interior surface of the vial, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
21,708 units
DISTRIBUTION
Nationwide, PR
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0269-12
CODE
Unit: W141607418116
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on December 5, 2007.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Platelets. Recall # B-0278-12
CODE
Unit: W035211256614L
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter and electronic mail on October 27, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and NJ
___________________________________
PRODUCT
Source Plasma. Recall # B-0290-12
CODE
Units: 0330119669, 0330119862, 0330120801, 0330121279, 0330125920, 0330127236, 0330128610, 0330128872, 0330129236
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., City of Industry, CA, by facsimile on August 8, 2007. 
Manufacturer: Biomat USA, Inc., Seattle, WA. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor with high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Spain
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0291-12
CODE
Unit: W141607012350-1
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by telephone on August 10, 2007. Firm initiated recall is complete.
REASON
Blood product, mislabeled as irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0297-12
CODE
Unit: W036511095423
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on November 5, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0300-12
CODE
Unit: 22GL91650
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on September 16, 2011 and by letter on September 19, 2011. Firm initiated recall is complete.
REASON
Blood product, manufactured from overweight whole blood units, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ, PA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0301-12
CODE
Unit: W03941109434400
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by fax on October 26, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was permanently deferred, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-0302-12
CODE
Units: RP107968; RP107970
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by electronic mail on August 25, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled with incorrect expiration dates, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Israel
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0303-12;
2) Recovered Plasma. Recall # B-0304-12
CODE
1) and 2) Unit: W0685113222196
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax and letter on October 6, 2011. Firm Initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, WA
___________________________________
PRODUCT
Granulocytes Irradiated. Recall # B-0306-12
CODE
Recall # FM68227 
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on November 5, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0307-12
CODE
Unit: LH00533 
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on October 25, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-0309-12
CODE
Unit: 019GE55808
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone on October 7, 2011 and by letter dated October 7, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0310-12
CODE
Units: 7209659 (2 units) 
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on June 8, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0311-12
CODE
Units 53LT12290 (Parts 1 & 2), 53LT12300
RECALLING FIRM/MANUFACTURER
Amer. National Red Cross-Greater Chesapeake & Potomac Region, Baltimore. MD, by facsimile on August 4, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0312-12
CODE
Unit: T73255
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on July 23, 2007. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0103-12
CODE
Units: FN25132 (Part 1); FN25132 (Part 2); FN25132 (Part 3); FN26342 (Part 1); FN26342 (Part 2); FN26325; FN27091 (Part 1); FN27091 (Part 2); FN26324 (Part 1); FN26324 (Part 2)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Antihemophilic Factor (Recombinant). Recall # B-0267-12
CODE
Units: TRA11802AC, TRA11810AC, TRA11803AC, TRA11803AD, TRA11810AA, TRA11805AA, TRA11805AB, TRA11805AC, TRA11819AA, TRA11808AC, TRA11816AA, TRB11820AA, TRA11806AC
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Thousand Oaks, CA, by letter on November 4, 2011. Firm initiated recall is ongoing. 
REASON
RECOMBINATE kits (containing the diluent vial (sWFI), mislabeled with an extended expiration date), were distributed.
VOLUME OF PRODUCT IN COMMERCE
57,395 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0268-12 
CODE
Unit: W141608392114
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on April 1, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not determined/documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0293-12
CODE
Units: 5180083495, 5180084094, 5180085060, 5180085544, 5180087209, 5180087924, 5180088472, 5180090043, 5180090587, 5180091461, 5180094903, 5180095156, 5180095787, 5180096123, 5180096701, 5180097070, 5180097713, 5180098086, 5180098608, 5180098971, 5180099677, 5180100053, 5180100728, 5180101234, 5180102143, 5180102859, 5180103207, 5180103912, 5180104359, 5180104979, 5180105423, 5180106295, 5180106641, 5180107423, 5180107751, 5180108550, 5180108973, and 5180109733 
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., South Bend, IN, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0294-12
CODE
Units: 5220031603, 5220031950, 5220032607, 5220032988, 5220033750, 5220034291, 5220034872, 5220036101, 5220036338, 5220036845, 5220037094, 5220037599, 5220038349, 5220038619, 5220039092, 5220039472, 5220039827, 5220040277, 5220040690, 5220041106, 5220041553, 5220042111, 5220042564, 5220042936, 5220043405, 5220044032, and 5220044381 
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Evansville, IN, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability was not adequately determined, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall #B-0295-12
CODE
Units: 5220064634, 5220064883, 5220065597, 5220067002, 5220067259, 5220067991, 5220068275, 5220068876, 5220069165, 5220069771, 5220070351, 5220070704, 5220071380, 5220071454, 5220072185, 5220072422, 5220073045, 5220073303, 5220074323, 5220074479, 5220075487, 5220075802, 5220076311, 5220076816, 5220077129, 5220077738, 5220078307, 5220078678, 5220079152
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Evansville, IN, by electronic mail on July 1, 2011. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
ALLERGENIC EXTRACT LENSCALE (Atriplex lentiformis), 1:20 v/v, in 5 mL (Scratch Prick Test), 10 mL and 50 mL sterile multiple dose vials --- The following special mixtures were produced in 10 mL and 50 mL vials for physicians using the affected lot of Lenscale extract (different concentrations on mixtures depending on doctor's formulas): Minor Weed Mix, Tamkin Fall Weed Mix, PF 2191 Paterson Cal Weed Mix, PF 891 EGB Weed Mix, PF 2317 Schultz All Weed Mix, PF 2089 Chipps Weed Mix #2, Special Minor Weed Mix, and PF 2265 HAAMA Weed Mix. Recall # B-0296-12
CODE
Bulk Lenscale lot # 0H00071A; Lenscale finished extract lot #s: 1B11172, 1D80474, 1D10052, 1F87462, 1G15592, 1J84552; Minor Weed Mix lot #s: 1C15182, 1D11682; Tamkin Fall Weed Mix lot # 1C15442; PF 2191 Paterson Cal Weed Mix lot #1F82612; PF 891 EGB Weed Mix lot # 1G11872; PF 2317 Schultz All Weed Mix lot #s: 1G14832, 1J83912, 1J86312, 1J86342, 1C86732, 1F84092, 1F84102; PF 2089 Chipps Weed Mix #2 lot # 1F85312; Special Minor Weed Mix lot # 1J11212; PF 2265 HAAMA Weed Mix lot # 1C84571
RECALLING FIRM/MANUFACTURER
Alk-abello, Inc., Port Washington, NY, by letters dated November 10, 2011. Firm initiated recall is ongoing.
REASON
Mislabeled Lenscale (finished allergenic extract) was distributed.
VOLUME OF PRODUCT IN COMMERCE
Lenscale: 14 vials x 5 mL, 13 vials x 10 mL, 4 vials x 50 mL; special mixtures: 1 vial x 10 mL, 35 vials x 50 mL (total 67 vials)
DISTRIBUTION
CA, TX, MI, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0305-12
CODE
Unit: LM00983
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Merced, CA, by telephone on October 11, 2006.   Firm initiated recall is complete.
REASON
Blood product, which failed to meet the manufacturer's specification for red blood cell percent recovery after leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0308-12
CODE
Unit: W141607412064
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on April 16, 2007 and by letter on November 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations. Recall # Z-0186-2012
CODE
Syringe Lot Number: 3558203; Kit Lot Numbers: 3581367, 3564511, 3538478
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation And Pentron Clinical, Orange , CA, by letter dated July 18, 2011. Firm initiated recall is ongoing. 
REASON
There may be a curing problem that may cause cemented crowns to fall off after use of the product.
VOLUME OF PRODUCT IN COMMERCE
336 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG.
Recall # Z-0187-2012
CODE
Serial numbers available from Invacare.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, by letters on September 19, 2011.
Manufacturer: Invacare Corp., Sanford, FL. Firm initiated recall is ongoing.
REASON
Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.
VOLUME OF PRODUCT IN COMMERCE
35,747 beds
DISTRIBUTION
Nationwide and United Arab Emirates, Dominican Republic, Egypt, Guam, Mexico, & Virgin Islands
___________________________________
PRODUCT
1) IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0195-2012;
 
2) IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0196-2012;
 
3) Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0197-2012;
 
4) Right IBO Blade, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0198-2012;
 
5) Left IBO Blade, for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. Recall # Z-0199-2012
CODE
1) Units: 06213017, 08269017, 06230017, 08297027, 06247017, 08322017, 06257017, 08325017, 06279017, 09020017, 06306017, 09050017, 06355027, 09083017, 07025017, 09135017, 07043017, 09209017, 07067017, 09233017, 07080017, 09246017, 07114017, 09330017, 07157017, 10046017, 07172017, 10074017, 07183017, 10083017, 07197017, 10091017, 07211017, 10180017, 07220017, 10194017, 07246017, 10217017, 07282017, 10231017, 07323017, 10266017, 07356017, 10272017, 08003017, 10327027, 08017017, 10335017, 08049017, 11004017, 08064017, 11012017, 08078017, 11080017, 08141017, 11119017, 08206017, 11153017, 08248017, 11165017;
 
2) Units: 06216017, 08336017, 06237017, 09021017, 06247017, 09050017, 06257017, 09083017, 06327017, 09135017, 06355017, 09197017, 07015017, 09209017, 07043017, 09231017, 07115017, 09233017, 07141017, 09246017, 07172017, 10027017, 07185017, 10046017, 07208017, 10091017, 07220017, 10148017, 07236017, 10188017, 07282017, 10217017, 07323017, 10228017, 08003017, 10251017, 08052017, 10267017, 08067017, 10327017, 08078017, 10335017, 08141017, 11004017, 08206017, 11012017, 08213017, 11098017, 08268017, 11118017, 08301017, 11159017, 08322017, 11165017;
 
3) Units: 06216017, 06230017, 06247017, 06313017, 06354017, 07067017, 07110017, 07183017, 07190017, 07225017, 07246017, 07323017, 08141017, 08269017, 08336017, 09021017, 09050017, 09083017, 09135017, 09317017, 10085017, 10091017, 10117017, 10148017, 10194017, 10217017, 10327017, 11010017, 11100017, 11119017, 11159017, 11167017;
 
4) Units: 06214017, 06248017, 07038017, 07114017, 08045017, 09139017;
 
5) Units: 06248017, 07023017, 07039017, 07114017, 09163017, 10278017
RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. of Stryker Corp., Portage, MI, by letter dated October 18, 2011.  Firm initiated recall is ongoing.
REASON
There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyelitis of the mandible, or a pathological fracture due to faulty intervention or a secondary infection.
VOLUME OF PRODUCT IN COMMERCE
12,631 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300. Recall # Z-0265-2012
CODE
Lots 11161AE2 to 11241AE2, Lots are numbered sequentially using the middle three numbers, i.e 161-241.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter dated October 25, 2011.
Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.
REASON
An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.
VOLUME OF PRODUCT IN COMMERCE
6307 probes, 847 of these units are at Stryker distribution sites.
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. Recall #Z-0278-2012
CODE
Softlab with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, through SCC Soft Computer's proprietary Task Management System on March 22, 2011.
Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
REASON
Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Symbia S Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0283-2012;
 
2) Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
Symbia T Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0284-2012
CODE
1) Serial numbers 1236 and 1555;
2) Serial numbers 12316, 1236 and 1013
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, letter dated October 14, 2011. Firm initiated recall is ongoing.
REASON
Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.  
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL, IL, TX
___________________________________
PRODUCT
Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Made in China; Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included). UPC Code – 892076002718. Recall # Z-0294-2012
CODE
Serial numbers: 4980000001 through 4980002909
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pelstar, LLC, Alsip, IL, by letter dated October 7, 2011.
Manufacturer: Beaverite International Limited, Kowloon, Hong Kong SAR. Firm initiated recall is ongoing.
REASON
There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst.
VOLUME OF PRODUCT IN COMMERCE
2,498 units
DISTRIBUTION
Nationwide, and Canada, New Zealand, Israel and Lebanon
___________________________________
PRODUCT
Multigent Vancomycin Calibrators; Product Usage: The Multigent Vancomycin calibrators are inended for use in the calibration of the multigent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections. Catalog number: 6E44-01. Recall # Z-0297-2012
CODE
a) Lot 59446762, Exp 3/31/12; b) lot 59391741, Exp 12/31/2011
RECALLING FIRM/MANUFACTURER
Microgenics Corp., Fremont, CA, by letter dated June 15, 2011. Firm initiated recall is ongoing. 
REASON
The third party control material is recovering high, and outside the published range. VOLUME OF PRODUCT IN COMMERCE
a) 809 kits; b) 651 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-0298-2012;
 
2) The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-0299-2012
CODE
1) Lot numbers: 0011-1443;
2) Lot numbers: 0006-1415
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 8, 2011. Firm initiated recall is ongoing.
REASON
1 US customer was operating the Advanced Perfusion System 1 to an unapproved, modified cable, which was in product development, to connect the system to an occluder for the Sarns Modular Perfusion System 8000. Five (5) of twelve (12) cables from Terumo Japan, which were in product development, were given to a US customer.
VOLUME OF PRODUCT IN COMMERCE
12 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 816571. Recall #Z-0300-2012;
 
2) Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 801041. Recall # Z-0301-2012;
 
3) Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment; Catalog number 801040. Recall # Z-0302-2012
CODE
1) Serial Number 5315;
2) Serial Numbers 0216, 0233, 0354, 0800, and 2588;
3) Serial Numbers 0138, 0708, and 0735
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 10, 2011. Firm initiated recall is ongoing. 
REASON
Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed at that time as there were not instructions on how to install it and there was a retaining ring that should have been added with the felt washer, but was not. As a result, the felt washer could come loose over time and could interfere with internal components of the pump. This interference could cause a non-recoverable pump stop which could require mitigation.
VOLUME OF PRODUCT IN COMMERCE
9 roller pumps
DISTRIBUTION
Nationwide, Canada and Europe
___________________________________
PRODUCT
The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist. Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
Catalog Number 16422. Recall # Z-0303-2012
CODE
Serial Number 1901
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone on November 7, 2011. Firm initiated recall is ongoing.
REASON
Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connections between the board and the transformer.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neo-plastic diseases, as determined by a licensed medical practitioner. Recall # Z-0305-2012
CODE
152019, 152448, 151076, 151954, 152454, 152117, 152452, 152393, 152394, 151942, 152163, 151955, 152176, 152222, 151931, 152388, 151141, 152365, 152303, 152358, 152353, 152359, 152352, 152362, 152305, 152468, 152481, 152469, 151812, 152432, 151260, 151952, 152370, 151396, 152301, 152248, 152425, 151155, 151156, 151157, 151412, 105984, 152307, 152308. 151443, 151545, 151628, 152207, 152271, 152373, 152371, 151080, 152211, 152158, 152392, 152331
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated March 9, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.
REASON
If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a zero value.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning. Recall # Z-0307-2012
CODE
Units: 6107 and 6115
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated June 23, 2011.
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON
There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Roche Cobas c 111 Analyzer; The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analyzes are measured photo-metrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0311-2012
CODE
Serial Numbers 50865, 50626, 50798, 50731, 50654, 50541, 51023, 50946, 50989, 50634, 50506, 50251, 50887, 50948, 50453, 50688, 51111, 50997, 51122, 50244, 50790, 50475, 50597, 50740, 50656, 50793, 51086, 50999, 51146, 50635, 50744, 50586, 50632, 50846, 1167, 50693, 50787, 50670, 50672, 51128, 50941, 50562, 50788, 50547, 51003, 50624, 50677, 50678, 50814, 51015, 50687, 50680, 50894, 50560, 51004, 50247, 50538, 51118, 50926, 50847, 50841, 51127, 50741, 50764, 50633, 51106, 51116, 50201, 51124, 50612, 51088, 50576, 51016, 50689, 50681, 50424, 51126, 50959, 50878, 50784, 50661, 50761, 50452, 50450, 50290, 50947, 51327, 50630, 50985, 50763, 50319, 50984, 50250, 50549, 50925, 50844, 50660, 50845, 50683, 50735, 51056, 50463, 50775, 50840, 50734, 50655, 50843, 50758, 50852, 50539, 50651, 50653, 50657, 50964, 50563, 50742, 50738, 50727, 50934, 50561, 50803, 51000, 51107, 50686, 50815, 50649, 50470, 50759, 50644, 51053, 50739, 50595, 51087, 50575, and 50679
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated October 18, 2011. Firm initiated recall is ongoing.
REASON
Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. The missing number of characters can be in any position, therefore it could be in the middle of a result, (e.g. 48.53 mmol instead of 148.53 mmol). The missing numbers or characters can affect any part of the printout, ( e.g. results, measurement units, or other text), possibly leading to incorrect treatment/diagnosis in some tests. Information presented on the analyzer screen , or transmitted to the host system are correctly displayed.
VOLUME OF PRODUCT IN COMMERCE
135 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures. Recall # Z-0312-2012
CODE
Units: 4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036, 4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated May 12, 2011.  
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON
Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions. Recall # Z-0319-2012
CODE
Units: 848, 849, 850, 851, 852, 853, 1032, 1033, 1034, 928, 929, 930, 931, 932, 801, 802, 803, 804, 805, 980, 981, 982, 983, 984, 889, 890, 891, 892, 893, 894, 908, 909, 910, 911, 912, 833, 834, 835, 836, 837, 843, 844, 845, 846, 847, 1017, 1018, 1019, 1020, 1021, 903, 904, 905, 906, 907, 883, 884, 885, 886, 933, 935, 936, 937, 940, 974, 975, 976, 977, 978, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated March 25, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.
REASON
Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
VOLUME OF PRODUCT IN COMMERCE
89 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elekta Synergy XVI R.4.5 and R4.6 Product Usage: To be used as part of radiation therapy treatment process. Recall # Z-0320-2012
CODE
Units: 105984, 151076, 151080, 151141, 151155, 151156, 151157, 151168, 151260, 151362, 151396, 151412, 151442, 151545, 151566, 151616, 151628, 151683, 151684, 151710, 151764, 151785, 151802, 151812, 151839, 151885, 151892, 151931, 151942, 151952, 151954, 151955, 152019, 152117, 152158, 152163, 152177, 152207, 152210, 152211, 152222, 152223, 152248, 152257, 152262, 152271, 152301, 152303, 152305, 152307, 152308, 152331, 152352, 152353, 152356, 152358, 152359, 152362, 152365, 152370, 152371, 152373, 152388, 152392, 152425, 152432, 152433, 152448, 152452, 152454, 152468, 152469, 152481, 152491, 152504, 152522, 152536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 14, 2011. 
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.
REASON
The software did not operate as expected.
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 87-6203-884-01, Revision H, August 2009 and 87-6203-884-22, July 2010. Recall # Z-0321-2012;
 
2) ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-002-00 Revision 2, 2008. Recall # Z-0322-2012;
 
3) ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-007-00 Revision 1, 2010. Recall #Z-0323-2012;
 
4) ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem, Nitrite Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splinted Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. Catalog Number 97-9990-006-00 Revision 1, 2010. Recall # Z-0324-2012
CODE
All lots for all devices
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated August 26, 2011. Firm initiated recall is ongoing.
REASON
This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
VOLUME OF PRODUCT IN COMMERCE
119,284 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin). Recall #Z-0341-2012
CODE
Lot Code: DP-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by telephone on September 27, 2011. 
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. Recall # Z-0356-2012;
 
2) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. Recall # Z-0357-2012;
 
3) Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU. Recall # Z-0358-2012
CODE
1) SN'S: P0103111 P0105711 P0106011 P0200111 P0200211 P0201111 P0201611 P0201811 P0202011 P0202111 P0202911 P0203111 P0203411 P0203711 P0203811 P0204011 P0204211 P0204311 P0204411 P0204611 P0204711 P0204811 P0204911 P0205211 P0205411 P0205511 P0205711 P0205611 P0205811 P0205911 P0206211 P0206311 P0206411 P0210711 P0212911 P0213811 P0213911 P0300211 P0300411 P0300711 P0300911 P0301011 P0301411 P0301511 P0301711 P0301811 P0302111 P0302311 P0302411 P0302511 P0302611 P0302711 P0302811 P0303011 P0303111 P0303211 P0303311 P0303511 P0303611 P0303711 P0304011 P0304111 P0304311 P0304411 P0304611;
 
2) SN'S: P0102211 P0102311 P0104611 P0104811 P0105011 P0105311 P0105411 P0105511 P0105911 P0106511 P0100311
 
3) SN'S: P0102011 P0203911 P0204511 P0302011 P03011211 P0303411 P0104911 P0105211 P0105811 P0106611
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated October 14, 2011.
Manufacturer: Integra, Burlington MA, Inc., Burlington, MA. Firm initiated recall is ongoing.
REASON
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110. Recall # Z-0364-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on November 4, 2011. Firm initiated recall is ongoing.
REASON
An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide Internationally
___________________________________
PRODUCT
1) Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0373-2012
 
2) Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0374-2012;
 
3) Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0375-2012;
 
4) Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0376-2012;
 
5) Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0377-2012;
 
6) Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0378-2012;
 
7) Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0379-2012;
 
8) Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0380-2012;
 
9) UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system is designed to deliver illumination from a high intensity light source for surgical site illumination. Recall # Z-0381-2012
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated October 10, 2011, via FedEx, email or telephone.
Manufacturer: Integra Burlington MA, Inc., Burlington, MA. Firm initiated recall is ongoing.
REASON
Headlight assembly (module) may become loose and separate from the headband assembly.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only. The device is intended to be used as a staple line buttress. Recall # Z-0274-2012
CODE
Lot # 5784583-1590912
RECALLING FIRM/MANUFACTURER
Synovis Surgical Innovation Div. of, Saint Paul, MN, by letter dated October 26, 2011. Firm initiated recall is ongoing.
REASON
Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.
VOLUME OF PRODUCT IN COMMERCE
132 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
Lloyd, Thyro-Tabs (levothyroxine sodium tablets, USP), 0.5 mg, packaged in 120 tablet bottles, NDC 11789-255-10. Recall # V-011-2012
CODE
Lot KD20510, Exp. 10/11; Lot KD20510A, Exp. 10/11
RECALLING FIRM/MANUFACTURER
Lloyd Inc., Shenandoah, IA, by letter dated August 31, 2011. Firm initiated recall is ongoing.
REASON
The product may not maintain potency throughout its labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
Lot # KD20510--5,412/120 ct bottles and Lot # KD20510A--583/120 ct bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) LLOYD INCORPORATED Thyro-Tabs (Levothyroxine sodium tablets, USP), each tablet contains 0.5 mg levothyroxine sodium USP, packaged in 1,000-tablet bottles, NDC 11789-255-20. Recall # V-012-2012;
 
2) LLOYD INCORPORATED Thyro-Tabs (Levothyroxine sodium tablets, USP), each tablet contains 0.3 mg levothyroxine sodium USP, packaged in 1,000-tablet bottles, NDC 11789-253-20. Recall #V-013-2012
CODE
1) Lot #KB21510, Exp. 11/11;
2) Lot #KD20510, Exp. 10/11
RECALLING FIRM/MANUFACTURER
Lloyd Inc., Shenandoah, IA, by letters dated May 5, 2011. Firm initiated recall is complete.
REASON
Bottles are labeled as 0.5 mg. but contain 0.3 mg. tablets and bottles labeled 0.3mg Thyro-Tabs may contain 0.5mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1) 1158/1000ct bottles; 2) 324/1000ct bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Plum A+ Single Channel Infusion Pump for Veterinary Use Only. List number 60529. Recall # V-014-2012
CODE
Serial numbers: 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315247, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315288, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315302, 14315303, 14315304, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315317, 14315318, 14315319, 14315320, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315420, 14315421, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315441, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315465, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters on October 6, 2011 and October 28, 2011.
Manufacturers: Hospira Inc., Morgan Hill, CA;  
Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia,  
Costa Rica. FDA initiated recall is ongoing.
REASON
Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur. 
VOLUME OF PRODUCT IN COMME RCE
467 pumps
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
Plum A+ Single Channel Infusion Pump for Veterinary Use Only; list number 60529. Recall # V-015-2012
CODE
Serial numbers 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315247, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315288, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315302, 14315303, 14315304, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315317, 14315318, 14315319, 14315320, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315420, 14315421, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315441, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315465, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on 10/06/11 and October 28, 2011. 
Manufacturers: Hospira Inc., Morgan Hill, CA;
Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. FDA initiated recall is ongoing.
REASON
Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting. 
VOLUME OF PRODUCT IN COMMERCE
467 Pumps
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR DECEMBER 14, 2011
 
#