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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 9, 2011

 

November 9, 2011                                                                                        11-45
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Pretzel Logic Cookies 6 Count; 2) individual cookies are not labeled and are sold through the firm's retail bakery counter. 1) UPC 23123700000 2) UPC 23125700000. Recall F-0046-2012;
CODE
All product purchased on or prior to August 23, 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: He Butt Grocery Co., San Antonio, TX, by press release on August 23, 2011.
Manufacturer: Labatt Food Service, LLC, San Antonio, TX. Firm initiated recall is ongoing.
REASON
The cookies contain undeclared pecans. 
VOLUME OF PRODUCT IN COMMERCE
2,660 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Cookies and Cream flavored Frozen Fruit Bar. Recall # F-0047-2012;
 
2) Esquimal Frozen Fruit Bar, Vanilla covered with chopped peanuts. Recall # F-0048-2012;
 
3) Chiles Rellenos con Queso Panela. Recall # F-0049-2012;
 
4) Pineapple flavored Frozen Fruit Bar. Recall # F-0050-2012;
 
5) Strawberry flavored Frozen Fruit Bar. Recall # F-0051-2012;
 
6) Mango flavored Frozen Fruit Bar. Recall # F-0052-2012;
 
7) Esquimal Frozen Fruit Bar, Strawberry covered with shredded coconut. Recall # F-0053-2012;
 
8) Esquimal Frozen Fruit Bar, Coconut covered with shredded coconut. Recall # F-0054-2012
CODE
The firm does not identify their frozen bars with any lot codes.
RECALLING FIRM/MANUFACTURER
Rainbow Tropic, Inc., Ontario, CA, by telephone and letter beginning August 25, 2011. FDA initiated recall is ongoing.
REASON
Esquimal frozen bar contains soy allergen and does not declare soy on the label;
Chiles rellenos contain wheat allergen and do not declare wheat on the label;
Pineapple flavored Fruit Bar contains FD&C color Yellow #6 and FD&C color Yellow #6 is not declared on the label;
Strawberry flavored Frozen Fruit Bar contains FD&C color Blue #1, and FD&C color Blue #1 is not declared on the label;
Mango flavored Fruit Bar contain FD&C color Yellow #6 and FD&C color Yellow #6 is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
6) Mango:289; 1) CookiesnCream:24; Pineapple:267,EsquimalStrawberry:92, Esquimal Vanilla:56; Esquimal Coconut:33; Chile Rellenos:14,741; Chile Rellenos: 14,760
DISTRIBUTION
CA, UT, AZ
___________________________________
PRODUCT
1) 8 oz. Shredded Iceberg sold under Farmers Market brand (UPC # 30034-30195) and Hy-Vee brand (UPC # 75450-12053). Recall # F-0055-2012;
 
2) Farmers Market brand in 7 oz Parisian Blend Salad, UPC # 30034-30259. Recall # F-0056-2012;
 
3) Farmers Market brand in 9 oz Leafy Romaine Salad, UPC # 30034-30364. Recall # F-0057-2012;
 
4) 12 oz Romaine Garden Salad sold under Farmers Market brand (UPC # 30034-30220) and Hy-Vee brand (UPC # 75450-12058). Recall # F-0058-2012;
 
5) Hy-Vee brand in 12 oz American Blend Salad, UPC # 75450-12047. Recall # F-0059-2012;
 
6) Hy-Vee brand in 12 oz Garden Supreme Salad, UPC # 75450-12046. Recall # F-0060-2012
CODE
BEST BY 14OCT2011 A106A and A106B
RECALLING FIRM/MANUFACTURERO
River Ranch Fresh Foods LLC, Salinas, CA, by e-mail and letter on October 13, 2011. Ohio initiated recall is ongoing.
REASON
The product lots were found to be contaminated with Listeria monocytogenes based on sampling and analysis by the Ohio State Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
2,154 cases
DISTRIBUTION
IA, OH, PA
___________________________________
PRODUCT
Cuban Sub***3-99***Ingredients: Cuban Bread (Bleached wheat flour [malted barley flour, niacin, reduced iron, potassium bromate, thiamine mononitrate, riboflavin, folic acid] water, palm oil, sugar, salt, yeast [Sorbitan monosterate, ascorbic acid]), Ham (Cured with water, dextrose, potassium acetate, salt, brown sugar, dodium phosphate, sodium diacetate, sodium erythorabate, sodium nitrate), Spiced Pork (pork, water, salt, sodium lactate, sodium phosphate, monosodium glutamate, spices, garlic, sodium diacetate), Salami (beef, pork, water, corn syrup solids, salt, spices, sodium erythrobate, sodium nitrate), Swiss cheese (pasteurized part-skim milk, cheese cultures, salt, enzymes), Dill pickles (fresh cucumbers, water, vinegar, salt, spices, garlic, calcium chloride, sodium benzoate, tumeric , polysorbate 80), Mustard (distilled vinegar, water, mustard seed, salt, tumeric, paprika, spice, garlic powder, natural flavor.*** Contains: Wheat, Soy, & Milk.***Net Wt 8.5 oz***KEEP REFRIGERATED***6 51993 67982 9. Recall # F-0071-2012
CODE
Lot 70511
RECALLING FIRM/MANUFACTURER
Gourmet Classic Salads, Inc., Lake Wales, FL, by telephone on July 11, 2011 and by letter dated July 12, 2011. Florida initiated recall is ongoing.
REASON
Sub may contain Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Spinach 2.5 lb bag for institutional use in clear plastic wrap, packed in cardboard carton; 4 x 2.5 lb per case; storage instructions: Keep Refrigerated. Recall # F-0073-2012
CODE
Manufacturer Code: A279 47166; Best If Used By Date: October 20, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Church Brothers, LLC, Salinas, CA, by press release, telephone, and e-mail on October 6, 2011.
Manufacturer: True Leaf Farms, San Juan Bautista, CA. FDA initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella following a random USDA microbiological sampling.
VOLUME OF PRODUCT IN COMMERCE
560 bags (to retailer) + 1953 cartons (to direct accounts)
DISTRIBUTION
CA and Canada
___________________________________
PRODUCT
1) Fresh Selections brand Hearts of Romaine in 10 oz. bag, UPC Code: 0-11110-91044-8.
Recall # F-0095-2012;
 
2) Fresh Selections brand Leafy Romaine 10 oz. bag, UPC Code: 0-11110-91046-2. Recall # F-0096-2012;
 
3) Fresh Selections brand Field of Greens 10 oz. bag, UPC Code: 0-11110-91042-4. Recall # F-0097-2012;
 
4) Fresh Selections brand Romaine Blend 10 oz. bag, UPC Code: 0-11110-91038-7. Recall # F-0098-2012;
 
5) HEB brand Spring Mix 5 oz. bag, UPC Code: 0-41220-19752-1. Recall # F-0099-2012;
 
6) Marketside brand Fresh Spinach 10oz bag, UPC Code: 6-81131-32946-0. Recall # F-0100-2012;
 
7) Marketside brand Caesar Salad Kit 14.6 oz. bag, UPC Code: 6-81131-38744-6. Recall # F-0101-2012;
 
8) Marketside brand Asian Salad Kit 15 oz. bag, UPC Code: 6-81131-53211-2. Recall # F-0102-2012;
 
9) Marketside Southwest Salad Kit 15oz bag, UPC Code: 6-81131-38747-7. Recall # F-0103-2012;
 
10) Marketside brand Premium Romaine 9 oz. bag, UPC Code: 6-81131-38753-8. Recall # F-0104-2012;
 
11) Marketside brand Premium Romaine Family 18 oz., UPC Code: bag 6-81131-38807-8. Recall # F-0105-2012;
 
12) Taylor farms brand Field Greens 8 oz. bag, UPC Code: 0-30223-04036-1. Recall # F-0106-2012
CODE
1) Code Date/Best Buy Date: TFRS277B07OOKR5L, Best By 10-18-11;
2) Code Date/Best Buy Date: TFRS277B07OOKR5H Best By 10-18-11
3) Code Date/Best Buy Date: TFRS277B07OOKR5F Best By 10-18-11;
4) Code Date/Best Buy Date: TFRS277B07OOKR5N Best By 10-18-11;
5) Code Date/Best Buy Date: TFRS277B07 Best By 10-20-11;
6) Code Date/Best Buy Date: TFRS277A07 Guaranteed Delicious By 10-21-11;
7); 8), 9), 10), and 11) Code Date/Best Buy Date: TFRS277B07 Guaranteed Delicious By 10-19-11;
12) Code Date/Best Buy Date: TFRS277B07 Best If Used By 10-20-11
RECALLING FIRM/MANUFACTURER
Taylor Farms Retail, Inc., Salinas, CA, by press release, e-mail and letter on October 19, 2011. Washington initiated recall is ongoing.
REASON
The products have the potential to be contaminated with Salmonella, Arizona following a random test conducted on the finished product by the Washington State Department of Agriculture. 
VOLUME OF PRODUCT IN COMMERCE
3,265 cases
DISTRIBUTION
AZ, CA, CO, FL, KY, MO, NM, NY, NC, OR, SC, TX, VA, WA, PR
___________________________________
PRODUCT
NANCY ADAMS Classics MINI S'MORES, Net Wt. 5.5 oz. (155g), UPC 6 18645 21923 9. The Mini S'Mores are packed in individually wrapped silver foil packages (bags) inside a red and silver box. --- A case contains 6 boxes. Recall: F-0107-2012;
CODE
Manufacturing code of either I1119 or I1120
RECALLING FIRM/MANUFACTURER
Nassau Candy, Hicksville, NY, by telephone and e-mail on October 18, 2011 and October 19, 2011 and by press release on October 19, 2011 and by letter and e-mail dated October 20, 2011. Firm initiated recall is ongoing.
REASON
The Nancy Adams Mini S'Mores may contain undeclared peanuts due to inadvertent miss-packaging of some bags of peanut clusters into boxes of the Mini S'Mores. 
VOLUME OF PRODUCT IN COMMERCE
127 cases (6 boxes per case)
DISTRIBUTION
Nationwide and possibly Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) H-E-B Cottage Cheese w/Pineapple. UPC Code 004122024784. Size 16 oz. Recall #
F-1749-2011;
 
2) H-E-B Small Curd Cottage Cheese. UPC Codes: 0004122095829. Size 16 oz.; 0004122086701. Size 24 oz. Recall # F-1750-2011;
 
3) H-E-B Fat Free Cottage Cheese. UPC Codes: 0004122024778. Size 16 oz.; 0004122066631. Size 24 oz. Recall # F-1751-2011;
 
4) H-E-B Low Fat Cottage Cheese. UPC Codes: 0004122024782. Size 16 oz.; 0004122055145. Size 24 oz. Recall # F-1752-2011;
 
5) H-E-B Large Curd Cottage Cheese. UPC Codes: 0004122083891. Size 16 oz.; 0004122068689. Size 24 oz. Recall # F-1753-2011;
 
6) H-E-B French Onion Party Dip. UPC Codes: 0004122074261; Size 8 oz.; 0004122045014. Size 16 oz. Recall # F-1754-2011;
 
7) H-E-B Jalapeno Dip. UPC Code 0004122083489. Size 8 oz. Recall # F-1755-2011;
 
8) H-E-B Green/Onion Party Dip. UPC Code 0004122055596. Size 8 oz. Recall # F-1756-2011;
 
9) H-E-B Ranch Style Dip. UPC Codes: 0004122077256. Size 8 oz.; 0004122052078. Size 16 oz. Recall # F-1757-2011;
 
10) H-E-B Chili Con Queso Dip. UPC Codes: 0004122039858. Size 8 oz.; 0004122052077. Size 16 oz. Recall # F-1758-2011;
 
11) H-E-B Roasted Garlic Dip. UPC Code 0004122080646. Size 8 oz. Recall # F-1759-2011;
 
12) H-E-B French Onion Dip. UPC Code 0004122024522. Size 24 oz. Recall # F-1760-2011;
 
13)H-E-B Sour Cream. UPC Codes: 0004122026665 8 oz.; 0004122025475 16 oz.; 0004122052076. Size 24 oz. Recall # F-1761-2011;
 
14) H-E-B Light Sour Cream. UPC Codes; 0004122010555. Size 8 oz; 0004122072487. Size 16 oz; 0004122066383. Size 24 oz. Recall # F-1762-2011;
 
15) H-E-B Fat Free Sour Cream. UPC Code 0004122000517. Size 16 oz. Recall # F-1763-2011;
 
16) H-E-B Sweetened Plain Yogurt. UPC Code 0004122030330. Size 32 oz. Recall # F-1764-2011;
 
17) H-E-B Blended Vanilla Yogurt. UPC Code 0004122030329. Size 32 oz. Recall # F-1765-2011;
 
18) H-E-B Blended Peach Yogurt. UPC Code 0004122030328. Size 32 oz. Recall # F-1766-2011;
 
19) H-E-B Blended Strawberry Yogurt. UPC Code 0004122030327. Size 32 oz. Recall # F-1767-2011;
 
20) H-E-B Light Strawberry Yogurt. UPC Code 0004122030325. Size 32 oz. Recall # F-1768-2011;
 
21) H-E-B Light Vanilla Yogurt. UPC Code 0004122030326. Size 32 oz. Recall # F-1769-2011;
 
22) H-E-B Fat Free Active Tub Vanilla. UPC Code 0004122030196. Size 24 oz. Recall # F-1770-2011;
 
23) H-E-B Fat Free Active Tub Plain. UPC Code 0004122030195. Size 24 oz. Recall # F-1771-2011;
 
24) H-E-B Fat Free Active Tub Strawberry. UPC Code 0004122030194. Size 24 oz. Recall # F-1772-2011;
 
25) H-E-B Active Lowfat Tub Vanilla. UPC Code 0004122030193. Size 24 oz. Recall # F-1773-2011;
 
26) H-E-B garlic Dip. UPC Code 00041220. Size 8 oz. Recall # F-1774-2011
CODE
Purchased between 06/18/2011 and 07/27/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: H-E-B San Antonio Retail Support Center (SARSC), San Antonio, TX, by press release on July 27, 2011.
Manufacturer: H.E. Butt Grocery Co., San Antonio, TX. Firm initiated recall is ongoing.
REASON
Possible presence of foreign material (metal foreign objects).
VOLUME OF PRODUCT IN COMMERCE
810,540 units
DISTRIBUTION
TX, Mexico
___________________________________
PRODUCT
1) Almond Pesto is a pasta sauce. It is sold in 4 oz and 8 oz plastic deli containers with a snap on lid, labeling is applied to the lid of the product. There is no UPC on label. The product is labeled in parts: "***ALMOND PESTO***Fresh Delicious Tempting***Ingredients: Almonds, Basil, Parsley, Parmesan Cheese, Olive Oil, Lemon Juice, Red Wine Vinegar, Spices***NO PRESERVATIVES- Keep Refrigerated 4 oz. Pkg***Freezes Well! Great on Pasta, Bread, Crackers, Fish, Chicken, Everything!***". Recall # F-1836-2011;
 
2) Roasted Cashew Pesto is a pasta sauce. It is sold in 4 oz and 8 oz plastic deli containers with a snap on lid, labeling is applied to the lid of the product. There is no UPC on label. The product is labeled in parts: "***ROASTED CASHEW PESTO ***Fresh Delicious Tempting*** Ingredients: Roasted Cashew & Garlic, Basil, Parsley, Parmesan Cheese, Olive Oil, Lemon Juice, Red Wine Vinegar, Honey, Spices***NO PRESERVATIVES***Keep Refrigerated 4 oz. Pkg***Freezes Well! Great on Pasta, Bread, Crackers, Fish, Chicken, Everything***". Recall # F-1837-2011
CODE
All codes and includes 090911.
RECALLING FIRM/MANUFACTURER
Sherry's Pasta, Medford, OR, by visit on August 29, 2011. FDA initiated recall is ongoing.
REASON
Undeclared allergen. The Almond Pesto and Roasted Cashew Pesto sauce contain Parmesan cheese but the ingredient statements do not declare milk. 
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR
___________________________________
PRODUCT
Chocolate Fiber One 90 Calorie Chewy Bars. 5-0.82 oz (23 g) bars UPC 16000-26164. Contains: Wheat, Soy and Milk. Recall # F-0043-2012
CODE
Better if Used By 19MAY2012BV
RECALLING FIRM/MANUFACTURER
General Mills, Inc., Minneapolis, MN, by letter, dated October 20, 2011.
Manufacturer: General Mills Inc., Belvidere, IL. Firm initiated recall is ongoing.
REASON
Some packages of Chocolate flavor Fiber One 90-Calorie Chewy Bars contain another product made with peanuts.
VOLUME OF PRODUCT IN COMMERCE
13,413 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Energy Natural Vitamins B-50 Balanced B-Complex, Energy Metabolism Natural Vitamins B-50 Balanced B-Complex Tablets, 50 count bottles. Take one tablet daily with a full glass of water, preferably after a meal. Product number 3655 (Bulk # 52); UPC Code 0 21130 78373 1. Recall # F-0061-2012
CODE
Lot # 219111-03, Expiring 12/11; Lot # 219111-09, Expiring 12/11; Lot # 235661-03, Expiring 09/12; Lot # 235661-06, Expiring 09/12; Lot # 235661-34, Expiring 09/12; Lot # 235661-44, Expiring 09/12; Lot # 235661-54, Expiring 09/12; Lot # 274248-05, Expiring 12/12; Lot # 274248-11, Expiring 12/12; Lot # 274248-16, Expiring 12/12; Lot # 293893-04, Expiring 04/13; Lot # 328350-02, Expiring 01/14; Lot # 330515-01, Expiring 01/14; Label Revision codes 00A and 01
RECALLING FIRM/MANUFACTURER
Recalling Firm: NBTY, Inc., Bohemia, NY, letters dated September 28, 2011.
Manufacturer: NBTY Acquisition LLC, Garden Grove, CA. Firm initiated recall is ongoing.
REASON
Undeclared wheat discovered during internal review. 
VOLUME OF PRODUCT IN COMMERCE
35,249 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gustafson Farm Chocolate Break Chocolate Drink Vitamin A & D added***Ingredients: Water, High Fructose Corn syrup, Whey Powder (a Milk Derivative), Nondairy creamer (Partially Hydrogenated Soybean oil, Corn syrup solids, Sodium Casenate (a Milk Derivative), Mono & Diglycerides, Sodium Citrate, Salt, Dipotassium Phosphate, Sodium Aluminsilicate, Carrageenan, Artificial Flavor), Cocoa, Salt, Guar Gum, Corn Starch, Xanthan Gum, Natural and Artificial Flavors, Carrageenan, Monoglycerides, Sodium Stearoyl Lactylate, Vitamin A Palmitate, Vitamine D3***0 71229 02900 4***1 Gal. (3.78 L)*** Processed and Packaged at Plant Stamped in Code***" Product is in 1 Gal plastic containers packed 4 gallons per case. Recall # F-0062-2012
CODE
Code Dates 81611, 82311, and 82911, Batch Number: 72611, 82211, 8811, 81311
RECALLING FIRM/MANUFACTURER
Sunshine State Dairy Farms, LLC, Plant City, FL, by telephone and e-mail on August 16, 2011. Firm initiated recall is ongoing.
REASON
The product did not declare the Wheat on the label.
VOLUME OF PRODUCT IN COMMERCE
1,349 cases
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Rosemary bread (singles and pull-apart rolls). Brand name: Di Lusso Rosemary, Di Lusso Rosemary Pullapart. Product label reads in part: "Di Lusso Rosemary Ingredients: Unbleached Flour, Biga (Unbleached Flour, Water, Yeast), Water, Sea Salt, Fresh Rosemary Net Weight: 1 lb. 2 oz." UPC code: "8 91689 00094 4" (singles) UPC code: "8 91689 00095 1" (pull-apart rolls). Recall # F-0063-2012;
 
2) Olive bread. Brand name: "Di Lusso Mediterranean Olive" Product label reads in part: "Di Lusso Mediterranean Olive Ingredients: Unbleached Flour, Biga (Unbleached Flour, Water, Yeast), Water, Sea Salt, Kalamata Olives***". UPC code: 8 91689 00091 3. Recall # F-0064-2012;
 
3) Challah bread. Brand name: "Di Lusso Challah" Product label reads in part: "Di Lusso Challah Ingredients: Unbleached Flour, Pasteurized Eggs, Sugar, Biga (Unbleached Flour, Water, Yeast), Milk, Butter, Water, Sea Salt Net Weight: 12 oz". No UPC code.
Recall # F-0065-2012
CODE
Sticker with date: "7.22"
RECALLING FIRM/MANUFACTURER
Northwest Premier Foods, LLC, Bend, OR, by visit on July 23, 2011. FDA initiated recall is complete.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
1) 95 loaves & 5 bags pull-aparts; 2) 1 loaf; 3) 2 loaves
DISTRIBUTION
OR
___________________________________
PRODUCT
Product is frozen Yellow Fin Tuna ground meat. Product packaging: plastic vacuum sealed bags. 1 carton: 2 boxes/11 lbs each / 1 lb bags; 22 packages per carton (11 packages in each box). Package labeling reads in part:"***Frozen Tuna Ingredient: Yellow Fin Tuna Treated with Carbon Monoxide to Retain Color Retention ***PRODUCT OF INDONESIA***Frozen Tuna Net wt: 11 lbs/5KGS***". Recall # F-0112-2012
CODE
Lot # 7013, DATE PACKED: 28051105 (May 28th, 2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Osamu Corp., Gardena, CA, by press release on October 13, 2011.
Manufacturer: PT. Super Saku Bali, Benoa- Bali, Indonesia. FDA initiated recall is ongoing.
REASON
FDA sampling revealed decomposition of product. Minced tuna was found decomposed. 
VOLUME OF PRODUCT IN COMMERCE
1,765 cartons
DISTRIBUTION
Nationwide, Canada, Europe, Mexico
___________________________________
PRODUCT
1) Mentaiko (Pollock Roe), sold under the following labels: Mentaiko Mash Style Economy, each case at 12/12 oz item code 236 Iwashi each case at 3/4 lbs item code 238, Karashi 16 oz item code 13357, Mentaiko Economy Mild each case at 16/8 oz item code3959, Mentai Mash each case at 12/6 oz item code 4374, Mentaiko Karataro each case at 50/201oz item code 10788, Daiei Mentaiko, each case at 50/1.76oz item code 10811, Daifuku Mentaiko each case at 27/5 oz item code 10822, Mentaiko Mash Gyomuyo 16 oz item code 13544, Mentaiko Kuzureko each case at 3/4.4 lbs item code 17243, Mentaiko 3/4.4 lbs item 17241, Mentaiko Kireko each case at 50/1.76 oz item code 17608, Korean Mentaiko each case at 27/5 oz item code 18226, Mentaiko 4oz item code 18681, Mentaiko 5.7 oz, each case at 16/5.7 oz item code 18682, Hakata Yamaya Mentaiko each case at 50/2.1 oz item code 18961, Ika Mentaiko each case at 12/6 oz item code 18962, Kazunoko Mentaiko each case at 12/6 oz item code 18965, Mentaiko Mash each case at 12/12oz item code 21741, Mentaiko Regular Mild each case at 12/1 lb item code 23112, Royal hot Mentaiko each case at 12/1 lb item code 23115, Honzuke Mentaiko each case at 12/1 lb item code 42355, Mentaiko ST each case at 3/4.4 lbs item code 47467, Jukusei Mentaiko each case at 50/1.76 oz item code 61479, Mutual Mentaiko each case at 12/1 lb item code 71886, Mutual Mentaiko Mash each case at 12/12 oz item code 71888, ANA Karashi Mentaiko 16 oz item code 10030A. Labeling reads in part: "Mentaiko ***Seasoned Pollack Roe***POLLACKE ROE, SALT, RICE WINE, RED PEPPER SORBITOL, MONOSODIUMGLUTAMATE, SOY SAUCE, YUZU. Recall # F-0066-2012;
 
2) Masago (Capelin Roe). Sold under the following names: Spicy Masago 16 lbs, item code 1308; Masago Natural each case at 4/4.4 lbs item code 1309; Icrest Masago each case at 4/2.2 lbs item code 10612; Masago 1 kg each case at 8/2.2 lbs item code 34171; Masago 2 kg each case at 6/4.4 lbs, item code 34172; Masago each case at 4/4.4 lbs, item code 67980. Product labeling reads in part:"Spicy Masago***Spicy Capelin Roes INGREDIENTS: CAPELIN ROE, SALT, VINEGAR HIGH FRUCTOSECORNSYRUP, SOY SAUCE MONOSODIUM GLUTAMATE, REDPEPPEREXTRACT FD & RED NO.40 & YELLOW NO.6.  Recall # F-0067-2012;
 
3) Black Cod Kasuzuke. Each case at 3/4 lbs item code 26799. Product label reads in part:"***Black Black Cod Kasuzuke***INGREDIENT: BLACK COD, RICE LEES, SALT RICE WINE, SOY SAUCE (WATER, SOYBEAN, SALT). Recall # F-0068-2012;
 
4) Salmon Kasuzuke. Each case at 3/4 lbs, item code 26780. Product label reads in part:"***Salmon Kasuzuke***INGREDIENT: SALMON, RICE LEES, SALT RICE WINE, SOY SAUCE (WATER, SOYBEAN, SALT). Recall # F-0069-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Yamaya USA Inc, Torrance, CA, by letter on October 17, 2011. FDA initiated recall is ongoing.
REASON
The product labeling does not declare the allergen of wheat. The firms products contain soy sauce. The soy sauce contains wheat as an ingredient which is not declared on the firms labeling.
VOLUME OF PRODUCT IN COMMERCE
16,165 cases
DISTRIBUTION
CA, NY, NJ, GA, MD, IL, CO, HI, FL, WA, NV, and one Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Natural Coconut Ingredients: Natural Coconut. This product may also contain trace amounts of peanuts & other tree nuts. Net Wt. 16 oz. (1 lb). Recall # F-0070-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Vending Nut Co Inc., Fort Worth, TX, by letter on January 25, 2011. FDA initiated recall is ongoing.
REASON
The product label failed to declare sulfites.
VOLUME OF PRODUCT IN COMMERCE
54 bags
DISTRIBUTION
TX
 
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.
 
RECALLS PENDING CLASSIFICATION: DRUGS
___________________________________
PRODUCT:
Neomycin Sulfate Tablets USP 500 mg (10 X 10 tabs per blister)
CODE
FGX
RECALLING FIRM/MANUFACTURER
Recalling Firm: X-Gen Pharmaceuticals, Horseheads, NY
Manufacturer: Patheon Inc., Whitby Operations, Whitby, Ontario, Canada
REASON FOR RECALL
Discoloration: Some tablets may be discolored/mis-shaped due to improper sealing of the blister foil packaging. 
_________________________________
PRODUCT
a) Plak-Vac Oral Care System, Memorial Hospital q2 Oral Care Kit;
b) Plak-Vac Oral Care System, St. John's Mercy Medical Center q2 Oral Care Kit;
c) Plak-Vac Oral Care System, Swedish Covenant Hospital, Non-Trach/Vent Oral Care Kit;
d) Plak-Vac Oral Care System, Swedish Covenant Hospital q4 Oral Care Kit;
e) Plak-Vac Oral Care System, Des Peres Hospital q4 Oral Care Kit;
f) Plak-Vac Oral Care System, University of Tennessee Medical Center q4 Oral Care Kit
CODE
a) Order No. 2381; Kit Lot #: 101011; CPC Mouthwash Lot # 13068;
b) Order No. 2330-A; Kit Lot #: 082611, 090611, 091211, 091411, 091611, 092611, and 092911; CPC Mouthwash Lot # 13068;
c) Order No. 2358; Kit Lot #: 092711, 0390016-090711, and 0390077-090811; CPC Mouthwash Lot # 13068;
d) Order No. 2329; Kit Lot #: 0390016-090711 and 0390963-101111; CPC Mouthwash Lot # 13068;
e) Order No. 2336; Kit Lot #: 389839; CPC Mouthwash Lot # 13068;
f) Order No. 2460; Kit Lot #: 092211; CPC Mouthwash Lot # 13068
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trademark Medical LLC, Ballwin, MO
Manufacturer: Birchwood Laboratories, Inc., Eden Prairie, MN
REASON FOR RECALL
Microbial Contamination of Non-Sterile Products: The mouthwash component of the kit was found to be contaminated with Burkholderia cepacia.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I 
___________________________________
PRODUCT
1) Slim Forte Slimming Capsule, 30-count capsules per box, InterCharm INC, UPC 6 913546 423827. Recall # D-827-2012;
 
2) Slim Forte Slimming Coffee, Instant Coffee, 10 g single use bag/packets, 12-count bag/packets per box. Recall # D-828-2012;
 
3) Meizitang Botanical Slimming 100% Natural Soft gel, 650 mg, 3 x 12-count capsules per blisters packaged in a pouch. Recall # D-829-2012
CODE
1) Batch #: 20100604, Best By 06.03.2012; 20100928, Best By 09.27.2012;
2) Batch Number: 20100903; Production Date: 09.03.2010; Valid Date (Best By): 09.02.2012;
3) Coding on each pouch: 12.24.2009, (Best By) 12.23.2011
RECALLING FIRM/MANUFACTURER
Intercharm, Inc., Hallandale Beach, FL, by press release on July 26, 2011 and July 27, 2011 and by letter on August 5, 2011. Firm initiated recall is ongoing.
REASON
FDA laboratory analyses found the products to contain Sibutramine, an appetite suppressant that was withdrawn from the market in October 2010 for safety reasons, making these products unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Ireland
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Tacrolimus, 0.5 mg CAP, NDC 00781-2102-01. Recall # D-720-2012;
 
2) Tacrolimus, 1 MG CAP, NDC 00781-2103-01. Recall # D-721-2012;
 
3) Tamoxifen Citrate, 10 MG TAB, NDC 00591-2232-60. Recall # D-722-2012;
 
4) Tamoxifen Citrate, 20 mg TAB, NDC 00093-0782-01. Recall # D-723-2012;
 
5) Tamsulosin Hydrochloride, 0.4 MG CAP, NDC number: 00093-7338-01; 00228-2996-11; 00597-0058-01; 62756-0160-88; 68382-0132-01. Recall # D-724-2012;
 
6) Temazepam, 7.5 MG CAP, NDC 00378-3110-01; 00406-9915-01; 00406-9915-03; 00406-9960-01; 53489-0648-01. Recall # D-725-2012;
 
7) Temozolomide, 100 mg CAP, NDC 00085-1366-01. Recall # D-726-2012;
 
8) Temozolomide, 20 MG CAP, NDC 00085-1519-01. Recall # D-727-2012;
 
9) Temozolomide, 250 MG CAP, NDC 00085-1417-01. Recall # D-728-2012;
 
10) Temozolomide, 5 MG CAP, NDC 00085-3004-01, 00085-3004-02. Recall # D-729-2012;
 
11) Tenofovir Disoproxil Fumarate, 300 MG Tablet, NDC 61958-0401-01. Recall # D-730-2012;
 
12) 12) Terazosin HCL, 2 MG, Caplet, NDC 00093-4337-01, 59746-0384-10. Recall # D-731-2012;
 
13) Terbinafine HCL, 250 MG, Tablet, NDC 00093-7294-56; 00378-5710-01; 00378-5710-93; 64705-0543-10; 67405-0543-03. Recall # D-732-2012;
 
14) Terbutaline Sulfate, 2.5 MG, Tablet, NDC 00115-2611-01; 00115-2622-01; 00527-1318-01. Recall # D-733-2012;
 
15) Terbutaline Sulfate, 5 MG, Tablet, NDC 00527-1311-01; Recall # D-734-2012;
 
16) Tetracycline HCL, 500 MG, Caplet, NDC 00591-2235-01. Recall # D-735-2012;
 
17) Theophylline Anhydrous, 80 MG/15 ML, NDC 49708-0644-90. Recall # D-736-2012;
 
18) Theophylline Anhydrous ER, 100 MG, Caplet, NDC 50474-0100-01. Recall # D-737-2012;
 
19) Theophylline Anhydrous ER, 200 MG, Caplet, NDC 50474-0200-01. Recall D-738-2012;
 
20) Theophylline Anhydrous ER, 300 MG, Caplet, NDC 50474-0300-01. Recall #
D-739-2012;
 
21) Theophylline Anhydrous ER, 400 MG, Caplet, NDC 50474-0400-01. Recall # D-740-2012;
 
22) Theophylline ER, 400 MG, Tablet, NDC 29033-0001-01. Recall # D-741-2012;
 
23) Theophylline ER, 450 MG, Tablet, NDC 50111-0518-01. Recall # D-742-2012;
 
24) Theophylline EXT Release, 100 MG, Tablet, NDC 50111-0483-01. Recall # D-743-2012;
 
25) Thera Plus, 5 ML/Cup, NDC 00001-0046-86. Recall # D-744-2012;
 
26) Thiamine, 100 MG, Tablet, NDC 00536-4680-01, 00536-4680-10, 00904-0544-60, 10939-0516-33, 37864-0905-01, 96295-0054-04. Recall # D-745-2012;
 
27) Thiamine Hydrochloride, 50 MG, Tablet, NDC number: 00536-4678-01. Recall # D-746-2012;
 
28) Thioridazine HCL, 10 MG, Tablet, NDC 53489-0148-01. D-747-2012;
 
29) Thioridazine HCL, 10 MG, Tablet, NDC 53489-0148-01. Recall # D-748-2012;
 
30) Thioridazine HCL, 50 MG, Tablet, NDC 00378-0616-01, 53489-0150-01. Recall # D-749-2012;
 
31) Thiothixene, 1 MG, Caplet, NDC 00378-1001-01, 00781-2226-01. Recall # D-750-2012;
 
32) Thiothixene, 10 MG, Caplet, NDC 00378-5010-01, 00781-2229-01. Recall # D-751-2012;
 
33) Thiothixene, 20 MG, Caplet, NDC 00049-5770-66. Recall # D-752-2012;
 
34) Thiothixene, 2 MG, Caplet, NDC 00781-2227-01. Recall # D-753-2012;
 
35) Thiothixene, 5 MG, Caplet, Distributed by: AidaPak Service, LLC, NDC number: 00378-3005-01, 00781-2228-01. Recall # D-754-2012;
 
36) Thyroid 1/2 Grain, 30 MG, Tablet, NDC 00456-0458-01, 42192-0329-01. Recall # D-755-2012;
 
37) Thyroid, 32.5 MG, Tablet, NDC 64727-3299-01. Recall # D-756-2012;
 
38) Thyroid, 60 MG, Tablet, NDC 00456-0459-01, 42192-0330-01. Recall # D-757-2012;
 
39) Tiagabine HCL, 4 MG, Tablet, NDC 63459-0404-30. Recall # D-758-2012;
 
40) Ticlopidine Hydrochloride, 250 MG, Tablet, NDC 00093-0154-01. Recall # D-759-2012;
 
41) Time Release B-50 Complex, Unit, NDC 00904-4184-52. Recall # D-760-2012;
 
42) Timolol Maleate, 10 MG, Tablet, NDC 00378-0221-01. Recall # D-761-2012;
 
43) Timolol Maleate, 5 MG, Tablet, NDC 00378-0055-01. Recall # D-762-2012;
 
44) Tizanidine HCL, 2 MG, Tablet, NDC 00037-8072-19, 00185-0034-51, 00378-0722-19. Recall # D-763-2012;
 
45) Tizanidine HCL, 4 MG, Tablet, NDC 00185-4400-51, 00378-0724-19. Recall # D-764-2012;
 
46) Tolazamide, 250 MG, Tablet, NDC 00378-0217-01. Recall #D-765-2012;
 
47) Tolterodine Tartrate, 1 MG, Tablet, NDC 00009-4541-02. Recall # D-766-2012;
 
48) Tolterodine Tartrate, 2 MG, Caplet, NDC 00009-5190-01. Recall #D-767-2012;
 
49) Tolterodine Tartrate, 2 MG, Tablet, NDC 00009-4544-02. Recall # D-768-2012;
 
50) Tolterodine Tartrate ER, 4 MG, Caplet, NDC 00009-5191-01, 00009-5191-02.
Recall # D-769-2012;
 
51) Topiramate, 25 MG, Tablet, NDC 13668-0031-60. Recall # D-770-2012;
 
52) Topiramate Sprinkle 15 MG, Caplet, NDC 00093-7335-06. Recall # D-771-2012;
 
53) Torsemide, 10 MG, Tablet, NDC 50111-0916-01. Recall # D-772-2012;
 
54) Torsemide, 100 MG, Tablet, NDC 50111-0918-01. Recall # D-773-2012;
 
55) Torsemide, 20 MG, Tablet, NDC 50111-0917-01, 62756-0763-88. Recall # D-774-2012;
 
56) Torsemide, 5 MG, Tablet, NDC 50111-0915-01. Recall D-775-2012;
 
57) Tramadol HCL, 50 MG, Tablet, NDC 00093-0058-01; 00378-4151-01; 57664-0377-08; 65162-0627-10; 65162-0627-11. Recall # D-776-2012;
 
58) Tramadol HCL ER, 100 MG, Tablet, NDC 10147-0901-03, 49884-0821-11. Recall # D-777-2012;
 
59) Trandolapril, 1 MG, Tablet, NDC 00093-7325-01, 00378-3241-01. Recall # D-778-2012;
 
60) Trandolapril, 2 MG, Tablet, NDC 00093-7326-01, 00378-3242-01. Recall # D-779-2012;
 
61) Trandolapril, 4 MG Tablet, NDC 00093-7327-01. Recall # D-780-2012;
 
62) Tranylcypromine Sulfate, 10 MG, Tablet, NDC 49884-0032-01. Recall # D-781-2012;
 
63) Trazodone HCL, 100 MG, Tablet, NDC 00603-6161-32, 50111-0434-01, 50111-0434-03. Recall # D-782-2012;
 
64) Trazodone HCL, 50 MG Tablet, NDC 50111-0433-01, 50111-0433-02, 50111-0433-03, 53489-0510-01. Recall # D-783-2012;
 
65) Trazodone Hydrochloride, 150 MG Tablet, NDC 50111-0441-01, 50111-0441-02. Recall # D-784-2012;
 
66) Tretinoin, 10 MG Caplet, NDC 00555-0808-02. Recall # D-785-2012;
 
67) Triamterene & HCTZ , 37.5/25 MG Tablet, NDC 00591-0424-01. Recall # D-786-2012;
 
68) Triamterene, 50 MG Caplet, NDC 65197-0002-01. Recall # D-787-2012;
 
69) Triamterene/Hydrochlorothiazide, 35.7/25 MG Tablet, NDC 00378-0464-01, 00378-2537-01, 00591-0424-01, 00781-1123-01. Recall # D-788-2012;
 
70) Triamterene HCTZ, 75/50 MG, Tablet, NDC 00591-0348-01. Recall # D-789-2012;
 
71) Trifluoperazine HCL, 2 MG Tablet, NDC 00378-2402-01, 00781-1032-01. Recall # D-790-2012;
 
72) Trifluoperazine HCL, 5 MG Tablet, NDC 00378-2405-01, 00781-1034-01. Recall # D-791-2012;
 
73) Trifluoperazine Hydrochloride, 1 MG Tablet, NDC 00378-2401-01. Recall # D-792-2012;
 
74) Trihexyphenidyl HCL, 2 MG Tablet, NDC 00143-1746-01, 00143-1764-01, 00591-5335-01, 00591-5335-10. Recall # D-793-2012;
 
75) Trihexyphenidyl HCL, 5 MG Tablet, NDC 00143-1763-01, 00591-5337-01, 00603-6241-21. Recall # D-794-2012;
 
76) Trimethobenzamide HCL, 300 MG Caplet, NDC 53489-0376-01. Recall # D-795-2012;
 
77) Trimethoprim, 100 MG Tablet, NDC 0591-5571-01. Recall # D-796-2012;
 
78) Trimipramine Maleate, 25 MG, Caplet, NDC 51285-0538-02. Recall # D-797-2012;
 
79) Triprolidine HCL/Pseudoephedrine HCL, 2.5 MG/60 MG, Tablet, NDC 00904-0250-59. Recall # D-798-2012;
 
80) Trospium Chloride, 20 MG, Tablet, NDC 00023-3513-60, 68462-0461-60. Recall # D-799-2012;
 
81) Trospium Chloride ER, 60 MG, Caplet, NDC 00023-9350-30. Recall # D-800-2012;
 
82) Univasc, 15 MG, Tablet, NDC 00091-3715-01. Recall # D-801-2012;
 
83) Ursodiol, 250 MG, Tablet, NDC 00093-5360-01, 58914-0785-10. Recall # D-802-2012;
 
84) Ursodiol, 300 MG, Caplet, NDC 00093-9380-01, 00591-3159-01. Recall # D-803-2012;
 
85) TOPIR AMATE SPRINKLE, 25 MG, CAPLET, NDC 00093-7336-06, 50458-0645-65. Recall # D-804-2012
CODE
1) Lot: 040801, Exp 05/16/12; BJ3686, Exp 03/29/12; BK4531, Exp 05/04/12; KW10A243, Exp 06/21/11, 06/30/11; KW10E344, Exp 09/15/11; KW10F777, Exp 10/20/11; KW10G148, Exp 11/30/11; KW10G212, Exp 03/13/12;
 
2) Lot: KW10D117, Exp 09/30/11; BK7625, Exp 03/31/12; KW10D118, Exp 09/02/11; KW10D209, Exp 09/30/11; KW10D254, Exp 09/30/11; KW10H539, Exp 01/11/12, 01/18/12; KW160G159, Exp 11/30/11; BJ7055, Exp 05/12/12;
 
3) Lot: 115850A, Exp 05/11/12;
 
4) Lot: 339611, Exp 11/08/11;
 
5) Lot: T57045, Exp 07/26/11; T57054, Exp 07/23/11; T57055, Exp 07/23/11; T57057, Exp 07/23/11; T57059, Exp 08/09/11; T57061, Exp 08/09/11; T57065, Exp 10/15/11; T57066, Exp 10/07/11; T57068, Exp 08/18/11, 09/03/11; T57069, Exp 09/10/11, 10/22/11; T57076, Exp 09/03/11, 09/10/11; T57086, Exp 10/29/11; T57091, Exp 10/22/11, 10/29/11; T74001, Exp 10/29/11; T74026, Exp 12/22/11; T74049, Exp 02/03/12, 02/18/12, 02/24/12; T74050, Exp 03/09/12; 10J26GCA, Exp 02/14/12; A1000013, Exp 06/04/11; JKK0324A, Exp 04/25/12, 05/04/12; MJ7765, Exp 06/03/11; MJ7766, Exp 06/03/11; MK3168, Exp 06/03/11; MK4032, Exp 07/15/11; MK5085, Exp 01/25/12; MK5086, Exp 10/28/11; MK5129, Exp 10/21/11; MK5134, Exp 10/14/11, 10/25/11, 10/27/11, 11/03/11; MK5586, Exp 11/03/11; MK5589, Exp 11/11/11, 11/19/11; MK5821, Exp 11/18/11, 11/19/11; MK5823, Exp 12/06/11; MK6019, Exp 12/08/11; MK6022, Exp 12/30/11; MK6575, Exp 01/13/12, 02/03/12, MK6755, Exp 03/06/12, 03/07/12; MK6822, Exp 02/14/12; MK7030, Exp 03/01/12; MK8070, Exp 03/20/12; MK8157, Exp 05/18/12; MK9513, Exp 05/08/12;
 
6) Lot: 2001822, Exp 09/01/11, 10/26/11, 11/23/11, 12/29/11, 01/12/12; 2001823, Exp 01/26/12, 03/01/12, 03/09/12, 04/13/12; 9915P75493, Exp 04/17/12; 9915M67877, Exp 08/31/11; 9915P76498, Exp 03/08/12, 03/28/12; 9960P75351, Exp 02/11/12, 04/11/12, 04/12/12, 04/26/12, 04/27/12, 05/04/12, 05/10/12, 05/19/12; 63050, Exp 06/03/11, 06/04/11, 06/23/11; 63376, Exp 07/26/11; 63377, Exp 10/31/11;
 
7) Lot: 0RSA005, Exp 02/08/12;
 
8) Lot: 0NCW010, Exp 05/17/12; 8NCW061, Exp 02/08/12; 9NCW008, Exp 02/08/12;
 
9) Lot: 0BTR009, Exp 05/17/12; OBTR005, Exp 02/08/12;
 
10) Lot: 9HLO009, Exp 05/17/12; OHLO015, Exp 05/17/12; 0HLO008, Exp 02/08/12;
 
11) Lot: 2006895, Exp 06/01/11; 2007436, Exp 06/17/11; 02008269, Exp 03/03/12; 02008271, Exp 03/03/12; '02007426, Exp 06/22/11; CMTH, Exp 05/16/12; XBG, Exp 08/10/11;
 
12) Lot: K3552, Exp 05/31/11; OP305, Exp 06/17/11;
 
13) Lot: T07037, Exp 06/16/11, 06/30/11; T07044, Exp 08/26/11; T07047, Exp 08/16/11; T07051, Exp 02/15/12; T07061, Exp 03/16/12; 3016372, Exp 06/18/11; 3018954, Exp 08/11/11; 3021069, Exp 03/06/12; 3017369, Exp 07/14/11; 3018954, Exp 10/21/11; 5431003B, Exp 05/17/12; 5431004A, Exp 05/17/12; 5439008a, Exp 11/30/11;
 
 14) Lot: H0030921, Exp 11/18/11, 04/11/12; H0031081, Exp 12/02/11; H0070961, Exp 12/29/11; H9071691, Exp 06/02/11; H0030941, Exp 10/27/11; H0070981, Exp 12/29/11; H0070991, Exp 04/27/12; 2010107107, Exp 02/07/12; 2010308341, Exp 02/07/12;
 
15) Lot: 2009475991, Exp 08/03/11;
 
16) Lot: 317840, Exp 04/04/12;
 
17) Lot: 1079124, Exp 04/11/12; 1079125, Exp 04/27/12;
 
18) Lot: C091313, Exp 01/06/12, 03/13/12;
 
19) Lot: C100053, Exp 03/03/12, Exp 04/11/12;
 
20) Lot: C100055, Exp 03/16/12, 03/17/12;
 
21) Lot: C071142, Exp 11/30/11;
 
22) Lot: THE100501, Exp 07/27/11;
 
23) Lot: 309176, Exp 10/31/11;
 
24) Lot: 313429, Exp 08/17/11;
 
25) Lot: 604976, Exp 09/23/11; 605422, Exp 09/23/11;
 
26) Lot: 101387, Exp 06/08/11; 102150, Exp 07/26/11, 08/06/11, 09/30/11; 102329, Exp 11/08/11, 11/18/11; 102638, Exp 03/07/12, 03/29/12, 04/06/12, 04/19/12, 04/21/12; 103190, Exp 04/27/12; 94039, Exp 06/03/11; 102332, Exp 11/16/11; 102638, Exp 04/07/12; 32582, Exp 08/25/11, 09/02/11, 09/08/11, 09/14/11; 32781, Exp 09/30/11, 10/08/11, 10/12/11, 11/04/11, 11/11/11, 11/19/11, 11/30/11, 12/07/11, 12/08/11, 12/13/11, 12/14/11, 12/16/11, 12/27/11, 12/28/11, 12/30/11, 03/01/12; 32782, Exp 01/07/12, 01/11/12, 01/18/12, 01/26/12; 33390, Exp 12/08/11, 01/13/12; 33412, Exp 01/31/12, 02/08/12; 33665, Exp 02/22/12, 02/24/12, 03/10/12; 34147, Exp 03/28/12, 03/30/12, 04/04/12, 04/12/12, 04/13/12, 04/18/12, 04/19/12, 04/25/12; 34230, Exp 04/28/12, 05/02/12, 05/10/12, 05/12/12, 05/15/12, 05/16/12; 27886804, Exp 05/27/11, 06/03/11; 29487002, Exp 06/09/11, 06/10/11, 06/14/11, 06/18/11, 01/28/12; 29487003, Exp 07/14/11, 07/16/11; 0DN1635, Exp 06/03/11; 0FN1006, Exp 07/21/11; '0GN1724, Exp 08/17/11; ODN1635, Exp 06/14/11; OLN1341, Exp 01/27/12; 28865, Exp 06/02/11, 06/10/11, 06/18/11, 06/30/11, 07/30/11, 08/16/11, 09/07/11, 09/15/11, 10/07/11; 33420, Exp 12/07/11, 04/17/12; 4860401, Exp 10/31/11, 02/03/12; 5002600, Exp 12/29/11;
 
27) Lot: 103001, Exp 05/04/12;
 
28) Lot: 64425, Exp 04/11/12;
 
29) Lot: 64425, Exp 04/11/12;
 
30) Lot: 3019992, Exp 10/18/11; 63325, Exp 07/27/11;
 
31) Lot: 2001646, Exp 09/03/11, 09/14/11, 10/08/11, 10/31/11; 205043, Exp 04/10/12;
 
32) Lot: 3022694, Exp 12/27/11, 01/06/12, 01/11/12; 197907, Exp 07/14/11, 08/06/11, 08/13/11; 202162, Exp 10/25/11;
 
33) Lot: O179K07A, Exp 11/12/11, 12/03/11, 12/06/11, 01/06/12;
 
34) Lot: 201191, Exp 09/14/11;
 
35) Lot: 2002182, Exp 12/14/11; 200492, Exp 11/17/11; 201251, Exp 12/10/11, 01/11/12;
 
36) Lot: 1074352, Exp 07/31/11; 1079406, Exp 11/30/11; 1085891, Exp 04/28/12, 05/12/12; 7932, Exp 04/04/12;
 
37) Lot: 030034-10C27, Exp 03/31/12;
 
38) Lot: 1075505, Exp 07/31/11; 1077414, Exp 10/20/11; 1077415, Exp 10/31/11; 1081721, Exp 01/31/12; 1084530, Exp 03/24/12, 03/30/12; 1084531, Exp 04/13/12; 7856, Exp 04/19/12, 04/30/12;
 
39) Lot: GB30109, Exp 07/19/11; GB30110, Exp 10/08/11, 01/11/12;
 
40) Lot: T15031, Exp 11/30/11, 01/11/12; T15033, Exp 08/31/11; T15036, Exp 04/04/12, 04/04/12;
 
41) Lot: 20672714, Exp 11/11/11, 11/30/11; 28115203, Exp 12/21/11, 01/21/12, 02/21/12, 02/22/12, 03/20/12, 04/06/12, 05/04/12, 05/15/12;
 
42) Lot: 3022419, Exp 01/27/12, 04/04/12;
 
43) Lot: 3016903, Exp 03/14/12;
 
44) Lot: 3018947, Exp 12/20/11; 3018948, Exp 01/13/12; BG9651, Exp 04/18/12; 3016885, Exp 07/23/11, 10/06/11; 3018943, Exp 10/11/11; 3018945, Exp 11/19/11; 3018948, Exp 03/14/12;
 
 
45) Lot: 202323, Exp 01/20/12; 3017047, Exp 07/23/11, 10/15/11; 3019135, Exp 10/25/11; 3019137, Exp 11/11/11, 11/19/11; 3022311, Exp 01/11/12; 3022315, Exp 02/15/12; 3022316, Exp 02/23/12; 3025281, Exp 03/28/12; 3025284, Exp 05/19/12;
 
46) Lot: 3009427, Exp 03/31/12; 3014992, Exp 01/19/12;
 
47) Lot: C100610, Exp 07/26/11, 08/16/11, 09/07/11; C100612, Exp 07/08/11, 12/08/11; C101450, Exp 11/11/11; C101503, Exp 01/21/12, 02/03/12, 02/21/12; C110023, Exp 04/04/12, 04/24/12, 05/05/12, 05/19/12;
 
48) Lot: C101768, Exp 02/15/12, 02/24/12, 05/04/12;
 
49) Lot: C100235, Exp 06/23/11; C100613, Exp 07/27/11, 07/28/11, 08/11/11; C100614, Exp 08/12/11, 08/17/11, 08/31/11, 09/07/11, 09/09/11; C101115, Exp 10/11/11, 10/13/11, 02/08/12; C101116, Exp 09/22/11; C101456, Exp 12/21/11, 01/04/12; C101517, Exp 11/24/11, 12/13/11; C101865, Exp 02/09/12; c110260, Exp 05/19/12;
 
50) Lot: C110013, Exp 02/24/12; C110016, Exp 02/22/12;
 
51) Lot: BF640012, Exp 08/03/11;
 
52) Lot: T44010, Exp 01/20/12, 02/03/12, 04/27/12;
 
53) Lot: 316584, Exp 11/09/11; 317756, Exp 03/13/12, 03/24/12; 317951, Exp 03/15/12; 317953, Exp 04/17/12; 50111-0916-01, Exp 10/08/11;
 
54) Lot: 313865, Exp 06/09/11;
 
55) Lot: 316404, Exp 10/22/11; 317712, Exp 03/01/12; 317713, Exp 01/10/12, 04/06/12; 317844, Exp 02/16/12; 317846, Exp 01/04/12; 317848, Exp 02/02/12; 161110A, Exp 04/24/12, 05/12/12; 301110A, Exp 05/09/12; JK93305A, Exp 09/03/11, 09/28/11; JKJ2272A, Exp 11/30/11, 12/15/11;
 
56) Lot: 471100A, Exp 05/17/12; 493090A, Exp 05/05/12;
 
57) Lot: 35202350A, Exp 04/19/12; 35320164A, Exp 04/06/12; 3015565, Exp 01/06/12; 3021594, Exp 04/28/12; GKJ0097A, Exp 01/31/12; HL14810, Exp 02/11/12; HJ34710, Exp 01/12/12;
 
58) Lot: 10B026P, Exp 09/24/11; 10M067P, Exp 04/11/12, 04/27/12; 22753201, Exp 10/13/11; 22821101, Exp 01/11/12;
 
59) Lot: T21017, Exp 06/08/11, 10/13/11, 10/14/11, 10/31/11; T21018, Exp 01/19/12; 2002029, Exp 04/19/12;
 
60) Lot: T22038, Exp 01/26/12; 3013802, Exp 10/31/11.
 
61) Lot: T23035, Exp 01/19/12; T23037, Exp 03/31/12;
 
62)Lot: 22674101, Exp 01/19/12;
 
63) Lot: T155F10C, Exp 09/30/11; 40999, Exp 10/25/11; 423040, Exp 10/25/11;
 
64) Lot: 294120, Exp 04/19/12; 461100, Exp 03/01/12; 358050, Exp 09/02/11; 382050, Exp 09/30/11; 432040, Exp 07/28/11; 159090, Exp 02/29/12; 161090, Exp 04/19/12; 314905, Exp 06/07/11; 315346, Exp 06/30/11; 339040, Exp 09/30/11; 63066, Exp 09/10/11, 11/24/11, 01/21/12; 64575, Exp 05/03/12;
 
65) Lot: 272120, Exp 04/26/12; 273120, Exp 05/02/12; 314060, Exp 02/22/12; 328100, Exp 03/24/12; 161070, Exp 03/14/12;
 
66) Lot: 703634, Exp 01/31/12; 603313A, Exp 04/07/12; 603314A, Exp 04/27/12, 05/11/12;
 
67) Lot: 66336A, Exp 05/19/12;
 
68) Lot: 0B7454, Exp 01/06/12, 01/11/12, 01/26/12, 03/31/12; 9F6090, Exp 07/14/11;
 
69) Lot: 3022674, Exp 04/18/12, 05/03/12; 3023723, Exp 01/28/12; 3024714, Exp 04/28/12; 245769-A, Exp 06/08/11; 42106A, Exp 10/12/11, 11/17/11, 12/07/11; 42110A, Exp 01/25/12; 43257A, Exp 11/23/11; 44278A, Exp 02/17/12; 50362A, Exp 03/16/12; 59868A, Exp 04/11/12; 193884, Exp 07/08/11; 196390, Exp 08/05/11, 12/08/11; 203944, Exp 02/15/12; BG9615, Exp 03/13/12, 03/15/12;
 
70) Lot: 44266A, Exp 10/26/11;
 
71) Lot: 3022071, Exp 02/09/12; 194557, Exp 11/03/11;
 
 72) Lot: 3014562, Exp 08/19/11; 192953, Exp 09/07/11, 09/21/11, 09/30/11; 202280, Exp 10/21/11, 11/02/11, 11/03/11, 11/12/11;
 
73) Lot: 3013153, Exp 09/23/11, 09/30/11; 3016890, Exp 10/19/11; 3022070, Exp 04/25/12;
 
74) Lot: 41578, Exp 08/24/11; 65692A, Exp 03/07/12; 67271A, Exp 06/02/11, 07/19/11, 07/23/11, 08/18/11, 06/24/11; 67272A, Exp 08/12/11, 09/10/11, 09/16/11, 10/11/11, 11/15/11, 12/07/11, 08/16/11; 276976M, Exp 07/22/11; 308629M, Exp 10/27/11; 319248M, Exp 03/14/12; 350165M, Exp 04/18/12; 145615B, Exp 06/17/11;
 
75) Lot: 67274A, Exp 06/02/11, 06/10/11, 06/16/11, 06/17/11, 06/22/11, 07/01/11, 07/09/11, 07/14/11, 07/30/11, 08/05/11, 08/06/11, 08/11/11, 08/16/11, 08/17/11, 08/20/11, 08/25/11, 12/13/11; 67275A, Exp 09/07/11, 09/13/11, 09/14/11, 09/24/11, 09/30/11, 10/07/11, 10/11/11, 10/15/11, 10/28/11, 11/15/11, 12/08/11, 12/10/11, 12/13/11, 12/22/11, 01/25/12, 02/03/12, 02/15/12, 03/01/12, 03/02/12, 03/09/12, 03/15/12; 68340B, Exp 03/24/12, 03/27/12, 04/07/12, 04/11/12, 05/05/12, 05/17/12, 05/19/12; 1109500663, Exp 06/18/11, 07/31/11; 281628M, Exp 07/15/11; 322986M, Exp 02/11/12; C1071210A, Exp 03/16/12, 03/17/12, 03/30/12, 04/25/12; C1180110A, Exp 08/05/11; C1210310A, Exp 11/18/11, 12/21/11; C1240910A, Exp 02/02/12, 02/22/12, 03/01/12;
 
76) Lot: 64491, Exp 03/23/12, 04/18/12; 64640-01, Exp 04/18/12; 64641-01, Exp 05/15/12;
 
77) Lot: 1110500195, Exp 10/22/11, 12/13/11; 1110500196, Exp 08/09/11, 01/06/12;
 
78) Lot: 317228, Exp 11/18/11;
 
79) Lot: P63549, Exp 10/08/11; P64797, Exp 02/08/12;
 
80) Lot: A1000461, Exp 07/16/11, 09/24/11; A1001139, Exp 09/07/11, 04/27/12; 02101938, Exp 11/19/11; 02102660, Exp 01/21/12;
 
81) Lot: 0913904, Exp 11/30/11; 1002002, Exp 11/19/11; 1002004, Exp 03/08/12; 1003861, Exp 02/23/12; 1003862, Exp 03/27/12, 04/13/12; 1003863, Exp 04/28/12, 05/10/12; '0913902, Exp 08/16/11; '0913903, Exp 09/10/11; '0913904, Exp 10/14/11;
 
82) Lot: 8758401, Exp 06/21/11;
 
83) Lot: U01010, Exp 07/12/11; U01015, Exp 03/30/12; 114430A, Exp 03/14/12; 114433A, Exp 02/28/12; 119520A, Exp 03/03/12; 120277A, Exp 05/12/12;
 
84) Lot: 998650, Exp 08/17/11; 998668, Exp 10/15/11, 10/21/11; 998672, Exp 11/19/11, 02/29/12; 998675, Exp 12/08/11; 998680, Exp 01/13/12; 998689, Exp 02/11/12; 998691, Exp 03/31/12, 04/27/12; 355199A, Exp 05/17/12;
 
85) Lot: 1BG555, Exp 05/12/12; T45015, Exp 07/31/11; T76001, Exp 04/25/12, 04/27/12; 1BG555, Exp 04/13/12
RECALLING FIRM/MANUFACTURER
Aidapak Services, LLC, Vancouver, WA, by letters on May 27, 2011, May 28, 2011 and May 31, 2011 and by press release on June 1, 2011. Firm initiated recall is ongoing.
REASON
Penicillin Cross Contamination; There is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.
VOLUME OF PRODUCT IN COMMERCE
Total 3,524,891 dosage units (124,759 units for drugs T-U)
DISTRIBUTION
AK, CA, OR, NV, and WA
___________________________________
PRODUCT
1) Colchicum autumnale, Tincture of fresh autumm crocus corm, 1:10, packaged in amber Boston round glass bottles in a) 30 mL, 120 mL, 240 mL, 480 mL, or 960 mL bottles.
Recall # D-816-2012;
 
2) Digitalis purpurea, Tincture of fresh digitalis leaf, 1:3, packaged in amber Boston round glass bottles in a) 30 mL, b) 120 mL, c) 240 mL, d) 480 mL, or e) 960 mL bottles; Recall # D-817-2012
CODE
1) COLC-AUT-TXR-10129780.1, no expiration date. COLC-AUT-TXR-09039780.1, no expiration date. This code COLC-AUT-TXR-10129780.1 may be observed on a label;
 
2) DIGI-PUR-TXR-09069530.1, no expiration date DIGI-PUR-TXR-06069530.1, no expiration date DIGI-PUR-TXR-05069530.1, no expiration date. 
RECALLING FIRM/MANUFACTURER
Heron Botanicals Inc., Poulsbo, WA, by letters and e-mails on October 22, 2011. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: FDA collected samples and detected colchicine in Colchicum autumnale and digitoxin in Digitalis purpurea. Because of their intended use these products are considered unapproved new drugs
VOLUME OF PRODUCT IN COMMERCE
2599 mL Colchicum autumnale; 8020 mL Digitalis purpurea
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Green Guard Iodine Prep pads, Almohadillas de Yodo, 12 packets per box, Order #6505. The pads within the box are Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), packaged 1 pad per foil packet labeled as TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1. Recall # D-830-2012;
 
2) 2 Shelf Super Utility Kit, metal kit containing 6-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, sold as (a) Green Guard Reorder #1125 with the Green Guard logo on the front of the kit; and (b) Green Guard Reorder #1125NS with blank front. Recall # D-831-2012;
 
3) 2 Shelf First Aid Cabinet, Restaurant Fill, metal kit containing 8-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet; TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, Green Guard Reorder #1125R with the Green Guard logo on the front of the kit. Recall # D-832-2012;
 
4) Tifco 2 Shelf First Aid Cabinet manufactured for Tifco Industries, cabinet containing 6-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet; TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, Green Guard Reorder #1125TIF. Recall # D-833-2012;
 
5) Special Fill First Aid Kit for Duke Electric, kit containing 3-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet; TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, Green Guard Reorder #1124DUKE with the Green Guard logo on the front of the kit. Recall # D-834-2012;
 
6) 5 Shelf First Aid Cabinet with no logo (blank front), cabinet containing 3-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet; TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, Green Guard Reorder #1180NS. Recall # D-835-2012;
 
7) Trauma Kit Fanny Pack, first aid red fanny pack containing 3-count packets of Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), 1 pad per foil packet; TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1, in addition to other items not listed here, Green Guard Reorder #1194. Recall # D-836-2012
CODE
Lot #: 8H404, Exp 07/11
RECALLING FIRM/MANUFACTURER
Unifirst Corp., Earth City, MO, by letter dated April 5, 2011. Firm initiated recall is complete.
REASON
Microbial Contamination of Non-Sterile Products: The products contain povidone iodine prep pads which were recalled by the supplier.
VOLUME OF PRODUCT IN COMMERCE
5705 boxes, kits, cabinets
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Plateletpheresis Leukocytes Reduced. Recall # B-0035-12
CODE
Units: 7672813 (BAG1); 7672813 (BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on September 17, 2007 and September 21, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, with unacceptably high platelet concentrations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0037-12;
2) Fresh Frozen Plasma. Recall # B-0038-12
CODE
1) and 2) Unit: 8310316
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on February 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0039-12
CODE
Units: FN30552, FN30552, FN27697, FN27697, FN30560, FN30560, FN30560, FN27704, FN27704, FN27704
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 9, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0040-12
CODE
Unit: LQ47169
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 20, 2007. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0041-12;
2) Red Blood Cells Leukocytes Reduced, Recall # B-0042-12;
3) Fresh Frozen Plasma. Recall # B-0043-12
CODE
1) Unit: 8266883;
2) Units: 8266883, 8269828;
3) Unit: 8269828
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakerfield, CA, by telephone and e-mail on January 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested repeat reactive for hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0044-12;
2) Red Blood Cells Leukocytes Reduced, Recall # B-0045-12
CODE
1) Unit: 84FT10213;
 
2) Units: 84FC01765; 84FT10193; 84FT10200; 84FT10220; 84FT11975; 84J19834; 84J19942; 84KK05231
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone and follow-up letter on March 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screenings were not adequately performed were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0046-12
CODE
Unit: FN23285
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 2, 2007. Firm initiated recall is complete.
REASON
Blood product, exposed to an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0047-12
CODE
Unit: W270110208787
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by fax on July 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0048-12
CODE
Unit: W035210074005; W035210073129S; W035210073139O; W035210073151W
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 12, 2011 and by telephone on September 6, 2011. Firm initiated recall is complete.
REASON
Blood products, with a red cell volume below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0049-12
CODE
Unit: W012107000163
RECALLING FIRM/MANUFACTURER
Department of the Army, Tamc, HI, by telephone on January 25, 2007 and follow up letter dated January 29, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested reactive for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced, Recall # B-0136-12;
2) Cryoprecipitated AHF. Recall # B-0137-12;
3) Recovered Plasma. Recall # B-0138-12
CODE
1), 2), and 3) Unit: 3229337
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by fax and e-mail on July 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0139-12
CODE
Units: W051511064129; W051511064144; W051511064144; W051511064153; W051511064153; W051511064129; W051511064153; W051511064166; W051511064166; W051511064191; W051511064193; W051511064193; W051511064109; W051511064109; W051511064078; W051511064095; W051511064119; W051511064119
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letters dated July 25, 2011 and September 6, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 Units
DISTRIBUTION
TN, SD, IA, MS, MI, MN, NY, NJ, NC, OH
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0140-12;
2) Fresh Frozen Plasma. Recall # B-0141-12
CODE
1) and 2) Unit: W036811080485
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone on August 10, 2011 and letter dated August 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0143-12
CODE
Units: W038111136925; W038111190955
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 18, 2011 and letters dated August 19, 2011 and September 9, 2011.
Manufacturer: Florida’s Blood Centers, Inc., Deland, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0144-12
CODE
Units: W038111120207; W038111063217
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Lake Park, Palm Beach Gardens, FL, by telephone and letter on August 30, 2011 and fax on September 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was a resident of a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0160-12;
2) Cryoprecipitated AHF, Pooled. Recall # B-0161-12;
3) Cryoprecipitated AHF. Recall # B-0162-12
CODE
1) and 3) Unit: W036809286526; 2) Unit: W036809823262
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by letter on September 8, 2011 and September 11, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0163-12
CODE
Unit: W149511309984
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone on August 23, 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
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0169-12;
2) Platelets. Recall # B-0170-12
CODE
1) Unit: W043208032481; 2) Unit: W043209032481
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on September 19, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0172-12
CODE
Unit: W036511079321
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by telephone on September 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who warranted deferral due to travel to a malaria/leishmaniasis endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0178-12
CODE
Unit: 53GL56795
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by facsimile on August 23, 2011. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as negative for the Fyb red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT:
1) Fresh Frozen Plasma. Recall # B-0180-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0181-12;
3) Red Blood Cells. Recall # B-0182-12
CODE
1) Units: 6549832; 6481287; 6455318; 6423802; 6390168;
2) Units: 6549832; 6481287; 6455318; 6390168; 6344229;
3) Unit: 6423802
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on June 21, 2011 and June 27, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed taking Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0183-12
CODE
Unit: W036511054506
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on September 29, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0019-12
CODE
Units: LQ41114; GG18621
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on April 27, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0020-12
CODE
Unit: 42FG44988
RECALLING FIRM/MANUFACTURER
American National Red Cross, Cleveland, OH, by electronic notification on September 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequatelydetermined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0036-12
CODE
Unit: PL9335785
RECALLING FIRM/MANUFACTURER
Exempla Healthcare, Denver, CO, by fax on October 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Source Plasma. Recall # B-0142-12
CODE
Unit: 11SLMB2922
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Mo, Saint Louis, MO, by fax on August 26, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was not asked any medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0163-12
CODE
Unit: W149511309984
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone on August 23, 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
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0164-12;
2) Plasma Frozen Cryoprecipitated Reduced. Recall # B-0165-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0166-12;
4) Cryoprecipitated AHF, Pooled. Recall # B-0167-12;
5) Red Blood Cells Leukocytes Reduced. Recall # B-0168-12
CODE
1) Unit: W0470113364990;
2) Unit: W047011342870;
3) Unit: W047011342870;
4) Units: W0470114679800; W0470113517930;
5) Units: W0470113385320; W0470113364990; W0470113428070; W0470113422680; W0470113373810; W0470113517930
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on August 14, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0171-12
CODE
Unit: W043209032481
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on September 19, 2011. 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
TN, NY
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient. Model numbers 5803, 5855, 5890, 5891, 5892, 5895, 5927, 5840-726, 5840-831, 5943, 5843A, 5996, 5996I and 6977. Recall # Z-0073-2012
CODE
All codes
RECALLING FIRM/MANUFACTURER
Mizuho Orthopedic Systems Inc., Union City, CA, by letters dated July 29, 2011. Firm initiated recall is ongoing.
REASON
Reports of injury related incidents while using the Mizuho OSI Modular Table System.
VOLUME OF PRODUCT IN COMMERCE
15011 devices; 1,616 of these went out of the US
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II ___________________________________
PRODUCT
CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient. Product Code: 03-2962-3. Recall # Z-3269-2011
CODE
Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804 Exp. Date 05-2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated August 11, 2011.  
Manufacturer: Fresenius Medical Care, Reynosa, Tamulipas, Mexico. Firm initiated recall is ongoing.
REASON
Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions.
VOLUME OF PRODUCT IN COMMERCE
118 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft. Part Number 800-1212. Recall # Z-0008-2012
CODE
Lot # 1038452
RECALLING FIRM/MANUFACTURER
Osteomed, LP, Addison, TX, by letter dated June 7, 2011. Firm initiated recall is ongoing.
REASON
Two of the Implant Driver Assembly tips were reported to break during surgery.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
PA, TX, CA, IL IA, FL, CT, MO
___________________________________
PRODUCT
MDC PACS - release R2.3 SP1. A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). Recall # Z-0032-2012
CODE
Sofware release R2.3 SP1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA,by letter dated August 2011.
Manufacturer: CDP LTD, PETACH TIKVA, Israel. Firm initiated recall is ongoing.
REASON
Clinical measurements on true size printouts may be inaccurate
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0124-2012;
 
2) SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Z-0125-2012;
 
3) SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0126-2012;
 
4) SYNCHRON CX5 Clinical System Part #: 759300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0127-2012;
 
5) SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0128-2012;
 
6) SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0129-2012;
 
7) SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0130-2012;
 
8) SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0131-2012;
 
9) SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine. Recall # Z-0132-2012
CODE
All non-PRO Software Versions.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter dated September 20, 2010. Firm initiated recall is ongoing. 
REASON
Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
VOLUME OF PRODUCT IN COMMERCE
4595 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired. Recall # Z-0142-2012
CODE
Catalog # 500AVHCT, CDI Blood Parameter Monitoring Systerm 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe; serial numbers 1038,1217,1381,1459,1461, 4260, 5048-5056, 5065-5077, 5082-5085,5094-5101,5118-5125,5142-5149,5158-5169, 5178, 5179, 5190,5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253,5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344,5354-5356,5370-5374, 5383, 5385, 5386, 5516-5521, and 5537-5541. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Serial numbers 1258, 1361, 1518, 1571, 1636, 1690,1717,1775,1875,1882, 2026,2292,2413,2459,2832, 2984,3092,3256,3313,3432, 3527, 3633, 3660, 3790, 3825, 4104, 5040-5047, 5057-5064, 5078-5081,5086-5093,5102-5117, 5126-5141, 5150-5157, 5170-5177,5180-5189,5191-5196, 5199-5209,5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281,5286-5289, 5294-5297,5306-5317,5322- 5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5529, 5531,5542,5543,and 5546-5556 Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules. Serial numbers 0033, 0051, 1465, 5330, 5331, 5332, 5333, 5338, 5339, and 5340. Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Serial numbers 1560 and 5349.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated September 23, 2011. Firm Initiated recall is ongoing.
REASON
Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.
VOLUME OF PRODUCT IN COMMERCE
432 units
DISTRIBUTION
Nationwide, Canada, Chile, Japan, Philippines, and Thailand
 
RECALLS AND FIELD CORRECTIONS: VETENINARY - CLASS II
___________________________________
PRODUCT
1) ANTISEDAN (atipamezole hydrochloride) Sterile Injectable Solution, 5.0 mg/mL, Net Contents 10 mL, NADA 141-033, Unit Package: Single Vials. Recall # V-004-2012;
 
2) DEXDOMITOR (dexmedetomidine hydrochloride) Sterile Injectable Solution - 0.5 mg/mL, Net Contents: 10 mL, NADA 141-267. Unit Package: Single Vials. Recall # V-005-2012
CODE
1) Lot 1399276, exp.03/2014;
2) Lot 1391999, exp. 01/2014
RECALLING FIRM/MANUFACTURER
Pfizer Inc., New York, NY, by letters dated September 9, 2011 and September 13, 2011. 
Manufacturers: Orion Pharmaceutica, Espoo, Finland; 
SGD (Saint Gobain Desjonqueres), Mers Les Bains, France.
Firm initiated recall is ongoing.
REASON
Some of the vials may contain foreign particles.
VOLUME OF PRODUCT IN COMMERCE
1) 1,772 bottles; 2) 14,479 bottles
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR NOVEMBER 9, 2011
 
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