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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 8, 2012

 

February 8, 2012                                                                                                 12-06
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Robert's S 1 cut leaf spinach; "Curly" spinach. There is no specific type of labeling on the 30 lb totes, except a small sticker label identifying the "pup" container which identifies the harvest date and the field. Field: Robert's S 1. Harvest Date City: Uvalde, Texas. Farmer: Jimmy Crawford. Pup container #s: "11-21 2011 TIRO TRES FARMS Roberts S1", "11-22 2011 TIRO TRES FARMS Roberts S1", "11-23 2011 TIRO TRES FARMS Roberts S1", "11-25 2011 TIRO TRES FARMS Roberts S1", "11-28 2011 TIRO TRES FARMS Roberts S1", "11-29 2011 TIRO TRES FARMS Roberts S1". Recall # F-0643-2012
CODE
a) 11/28/2011;.11-21 2011; 11-22 2011; 11-23 2011; 11-25 2011; 11-28 2011; 11-29 2011
RECALLING FIRM/MANUFACTURER
Tiro Tres Farms, Eagle Pass, TX, by letters on December 31, 2011. Firm initiated recall is ongoing.
REASON
Product tested positive for E-coli O157:H7.
VOLUME OF PRODUCT IN COMMERCE
228,360 lbs
DISTRIBUTION
CO, KY, MA, PA, and Ontario and Quebec, Canada
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PRODUCT
Serrano Chili peppers shipped under the Cal Fresco (5, 10 & 20 lb cases) and Comercializadora Frutus Y Legumes (40 lb cases) labels. Recall # F-0644-2012
CODE
Lot Code #205467 Please note that the lot coding also includes a Julian date (first 3 numbers of the lot code) as well as the year of distribution (last 2 digits of the lot code). The lot code will appear as the 4th through 9th digits of the lot code. Example: Lot code # 33720546711. 337 is the Julian date (in this case, December 3rd), and the next 6 digits are the lot code of the affected product (205467). The last two digits indicate the year of distribution.
RECALLING FIRM/MANUFACTURER
Cal Fresco, LLC, Buena Park, CA, by press release and letter on December 21, 2011.
Manufacturer: Comercializadora de Frutas y Legumbres,SRL de CV, Tijuana, Mexico. FDA initiated recall is ongoing.
REASON
The Serrano peppers may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
319 units (3,335 lbs)
DISTRIBUTION
Nationwide, Canada: Edmonton, Winnipeg, and Vancouver
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PRODUCT
Product is labeled in part: "***LEASA Living alfalfa Sprouts***CHOLESTEROL FREE!***PRESERVATIVE FREE!***KEEP REFRIGERATED NET WT. 6 OZ. (168g)***RINSE IN ICE-COLD WATER & GENTLY DRY BEFORE SERVING*** Product of USA***0 75465 55912 7. Recall # F-0659-2012
CODE
Use By Date 2/01/12
RECALLING FIRM/MANUFACTURER
LEASA Industries Co., Inc., Miami, FL, by telephone and email on January 18, 2012 and press was released on January 19, 2012. Florida initiated recall is ongoing.
REASON
The product tested positive for Salmonella by the Florida Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
346 cases
DISTRIBUTION
FL, GA, AL, LA and MS
___________________________________
PRODUCT
Sliced Herring Fillet (Forelka) 330 gram and 600 gram 21.1 oz. plastic container. Recall # F-0660-2012 
CODE
Best Before 03/06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zip International Group L.L.C., Edison, NJ, by press release dated January 10, 2012 and by letter on January 12, 2012.
Manufacturer: Pleyady L.T.D., Boyarka, Ukraine. New York Initiated recall is ongoing.
REASON
NYSDAM routine sampling has revealed Listeria contamination in sliced herring fillet (Forelka).
VOLUME OF PRODUCT IN COMMERCE
40 cases
DISTRIBUTION
NY
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PRODUCT
Gourmet Stuffed Clams --- Net Wt. 5oz. Each --- UPC: 209181201798 --- product is received in bulk by individual retail stores. It is then repacked into 5oz plastic containers and labeled at the point of sale with the Price Chopper label. Recall # F-0661-2012
CODE
Distributed between September 30, 2011 and December 30, 2011
RECALLING FIRM/MANUFACTURER
Price Chopper, Schenectady, NY, by telephone on January 3, 2012 and by press release on January 13, 2012. Firm initiated recall is complete.
REASON
This product is being recalled due to the fact that it contains milk, wheat and eggs, three known allergens, which are not listed on the store generated ingredient label.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, MA, VT, PA, CT, NH
___________________________________
PRODUCT
Guava Sticks ("Palitos de Guayaba") packaged in 7 oz plastic bags, 11 oz cans and 10 units paper packs. Recall # F-0700-2012
CODE
No code
RECALLING FIRM/MANUFACTURER
Enhorabuena! Inc., Bayamon, PR, by email on December 29, 2011 and press release (Spanish) and (English) version on websites, on January 3, 2012. FDA initiated recall is ongoing
REASON
Undeclared milk, wheat and eggs.
VOLUME OF PRODUCT IN COMMERCE
39, 000 units
DISTRIBUTION
PR
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
1) Cheddar Cheese Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0645-2012;
 
2) White Cheddar Cheese Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0646-2012;
 
3) Spicy Cheese Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0647-2012;
 
4) Macadamia Butter Crunch Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0648-2012;
 
5) Caramel Nut Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0649-2012;
 
6) Cookies and Cream Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0650-2012;
 
7) Rainbow Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0651-2012;
 
8) Gourmet Caramel Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0652-2012;
 
9) Chocolate Drizzle Caramel Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0653-2012;
 
10) Chicago Style Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0654-2012
RECALLING FIRM/MANUFACTURER
Third Coast Popcorn Partners, LLC dba Popcorn Palace, Schiller Park, IL, by letter on December 19, 2011. FDA initiated recall is ongoing.
REASON
The bags of popcorn do not have the list of ingredients or the allergen statement listed on the label.
VOLUME OF PRODUCT IN COMMERCE
24,526 1-gallon bags (Total for Class III Recall F-0655 and Recall F-0656-2012 also)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Courtier's Pepin Heights HoneyCrisp 100% Fresh Pressed Apple Cider, Flash Pasteurized, 64 Fl oz (2 qt) 1.89 L. The product was packaged in half-gallon plastic jugs. Recall # F-0657-2012
CODE
Use By FEB 09 12
RECALLING FIRM/MANUFACTURER
Pepin Heights Orchard, Inc., Lake City, MN, by telephone or e-mails and press release on January 6, 2012. Minnesota initiated recall is ongoing.
REASON
The product contains higher than allowable Patulin level.
VOLUME OF PRODUCT IN COMMERCE
694 Cases (6246 - Gallon Jugs)
DISTRIBUTION
MN, WI, IA
___________________________________
PRODUCT
Conte's Pasta Heart Shaped Lobster Ravioli in either Net Weight: 10 lbs. cases (2/5 lb plastic bags) or 16 oz trays; 7 34158 44001 3 310 E. Recall # F-0658-2012
CODE
Use by: 08/03/2012 Use by: 08/04/2012
RECALLING FIRM/MANUFACTURER
Contes Pasta Company, Inc., Vineland, NJ, by letter on November 3, 2011. Firm initiated recall is ongoing.
REASON
Product label does not include "wheat' as a sub-ingredient of durum flour.
VOLUME OF PRODUCT IN COMMERCE
28.5 cases (bulk case = 2 5 lb bags); 80 -16 ounce trays
DISTRIBUTION
NJ, PA
___________________________________
PRODUCT
Product is in a glass bottle with a plastic cap. The cap reads in part: "Garry's Meadow Fresh Qt. Grade A Pasteurized Egg Nog Qt. INGREDIENTS: Grade A Milk And Cream, Sugar, Grade A Nonfat Milk Powder (A Milk Derivative), Egg Yolks, Grade A Whey Powder (A Milk Derivative), Natural And Artificial Flavoring (Maltodextrin, Natural And Artificial Flavors, Modified Food Starch), Stabilizer Guar Gum, Carrageenan), Corn Starch, Salt, Nutmeg, Annatto-Tumeric (Color). Contains: Milk, Egg. 0 89958 80192 1." Recall # F-0663-2012
CODE
Stick-on label with 12/29/11
RECALLING FIRM/MANUFACTURER
Lady Lane Farm, Mulino, OR, via telephone on December 28, 2011. Oregon initiated recall is ongoing.
REASON
The egg nog was not adequately pasteurized. The egg nog was not held for the required amount of time at the required temperature to achieve an adequate pasteurization.
VOLUME OF PRODUCT IN COMMERCE
125 - one quart bottles
DISTRIBUTION
OR
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PRODUCT
1) Milk Chocolate Covered Pretzel Rod w/Christmas sprinkles 805421300248 7. Recall # F-0687-2012;
 
2) Milk Chocolate Rice Krispie Treat Christmas Sprinkles 854213002272. Recall # F-0688-2012;
 
3) Milk Chocolate Covered Marshmallows Holiday Sprinkles 854213002296, Recall # F-0689-2012;
 
4) S'mores Christmas Sprinkles 854213002302. Recall # F-0690-2012;
 
5) Milk Chocolate Oreos Christmas Sprinkles 854213002418. Recall # F-0691-2012
CODE
Lot: 1111, 1211
RECALLING FIRM/MANUFACTURER
2 CHICKS WITH CHOCOLATE, INC., South River, NJ, by telephone on January 6, 2012. Firm initiated recall is ongoing
REASON
Undeclared wheat ingredient on pretzel product label. Additionally, firm did not list sub ingredients on products containing sprinkles. Sprinkles contain FD&C colors including FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
NJ, AZ, Washington, DC
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Market Pantry pure honey grade A Net Wt 12 oz (340g). Recall # F-0640-2012
CODE
Lot 1174 with an expiration date "Best By 27 JUN2013"
RECALLING FIRM/MANUFACTURER
Honeytree, Inc., Onsted, MI, by letter on December 17, 2011. Firm initiated recall is ongoing.
REASON
Product contained 10.3ppb of sulfathiazole.
VOLUME OF PRODUCT IN COMMERCE
3525 cases (42300 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Kettle Corn Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0655-2012;
 
2) Sea Salt and Cracked Pepper Popcorn Palace Fundraising World's Best Gourmet Popcorn packaged in a Value Bag plastic 1 gallon bag. Recall # F-0656-2012
CODE
All product purchased after October 1, 2011 through one of Popcorn Palace's fundraising programs.
RECALLING FIRM/MANUFACTURER
Third Coast Popcorn Partners, LLC dba Popcorn Palace, Schiller Park, IL, by letter on December 19, 2011. FDA initiated recall is ongoing.
REASON
The bags of popcorn do not have the list of ingredients or the allergen statement listed on the label.
VOLUME OF PRODUCT IN COMMERCE
??????? 24,526 1-gallon bags ?????????
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Meche's Fresh Husk Tomatillos; 38 lbs packed in black wire or plastic mesh cartons. Recall # F-0662-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: C & S Wholesale Grocers, Stockton, CA, by e-mail on December 2, 2011.
Manufacturer: Agrupacion de Productores Agricolas de las Californias AC, Tijuana,   
Mexico. California initiated recall is complete.
REASON
The amount of pesticide residue (Captan) found in the product is above EPA's established tolerance level. This is based on the State of California's analysis.
VOLUME OF PRODUCT IN COMMERCE
428 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Black Mediterranean Mussels. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0667-2012;
 
2) Fresh Clam Venus shelled. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0668-2012;
 
3) Fresh Arrowtooth filet packed as 5 pound filets. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firms name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0669-2012;
 
4) Fresh Bass Striped filet. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firms name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0670-2012;
 
5) Fresh Black Cod filet sold as true, jcut, and port. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firms name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0671-2012;
 
6) Fresh Catfish available as filet, nuggets, and p/ready. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm’s stick on barcode label identifying the lot number and distributor. Recall #F-0672-2012;
 
7) Fresh Tilapia Filets. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0673-2012;
 
8) Fresh Dungeness Crab. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0674-2012;
 
9) Fresh Dover Sole Filets. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0675-2012
 
10) Fresh Salmon available as Filets, whole, port and trim in different commercially available weight quantities. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0676-2012;
 
11) Fresh Oysters in shell sold as Extra Value, BBQ, Dabob, EC MED, Fish Point, Golden Mantle, Kumamoto, Kushi Ex-small, Penn Cove Select, and Sister Point SM. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0677-2012;
 
12) Fresh Halibut sold as filet/bones. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0678-2012;
 
13) Fresh Mahi Mahi sold as 8 oz port. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall # F-0679-2012
 
14) Fresh Blue Marlin sold as loin. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0680-2012;
 
15) Fresh Ono Loin Filet. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firm’s name" and has a barcoded sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall #F-0681-2012
 
16) Fresh Rock Fish sold as Port, and Filet. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: "Firms name" and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firms stick on barcode label identifying the lot number and distributor. Recall #F-0682-2012
 
17) Fresh Trout sold as 8 oz, 10.5 oz, Butterfly cut, Clearcut, DSRD 12-20 oz, and 8 oz filet. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: Firms name and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firms stick on barcode label identifying the lot number and distributor. Recall #F-0683-2012;
 
18) Cocktail sauce 1/2 gallon. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: Firms name and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firms stick on barcode label identifying the lot number and distributor. Recall # F-0684-2012;
 
19) Fresh Scallops (Bay and Sea). The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: Firms name and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firm's stick on barcode label identifying the lot number and distributor. Recall # F-0685-2012;
 
20) Fresh Steelhead sold as filet, port, DSRD, and trim. The firm is a distribution facility who packages fresh seafood as follows: Fresh fish products are packaged in transparent plastic liners topped with ice (or gel ice), and then inserted into a cardboard shipping container for distribution. Live shellstock are packed in mesh liners, and shucked shellfish are in tubs and then placed in shipping containers (styrofoam or cardboard). There is no other consistency product to product and products are identified in one of two ways: 1) box in box out: products are shipped out with the original packers master case with a sticker label applied at the firm; and 2) processed items: products are shipped out with Pacific Seafood master case with a sticker label applied at the firm for traceability reasons. Examples of each type of labeling were provided but the firm can't be certain how the recalled product was identified. If shipped in the firm's cardboard container, labeling read: Firms name and has a barcode sticker applied to the outside of the box with product and lot number information. If shipped in the manufacturer's original packaging, the container would have the manufacturer's label along with Firms name stick on barcode label identifying the lot number and distributor. Recall # F-0686-2012
CODE
1) Lots: 956454, 954198, 952576;
 
2) Lots: 953003, 953994;
 
3) Lots: 955825, 952054;
 
4) 956754, 956224, 956754, 956224; 
 
5) Lots: 34897, 953000, 951077;
 
6) Lots: 951767, 959144, 958037, 948626, 951768, 958043;
 
7) Lots: 948649, 94850, 947910, 953007, 955382, 951646, 953004, 951645, 953005, 953488, 951644;
 
8) Lots: 956071, 956078, 955179, 955890, 953101;
 
9) Lots: 955812, 953002, 951075;
 
10) Lots: 955480, 953887, 955580, 955579, 953883, 954022, 955805, 955800, 955802, 953584, 955797, 953582, 954019, 953553, 952465, 956198, 952466, 955480, 953875, 955544, 955480, 953873, 955576, 950450, 955545, 955543, 953871, 955542, 951490, 950461, 952465, 953553, 955566, 955481, 953865, 953878, 952741;
 
11) Lots: 952614, 948586, 954194, 952579, 957715, 952874, 954311, 954197, 956461, 954121, 956442, 954202, 956451, 952577, 954195;
 
12) Lot: 911371;
 
13) Lot: 944470;
 
14) Lot: 955099;
 
15) Lots: 955607, 842503;
 
16) Lots: 955826, 952999, 951079;
 
17) Lots: 954126, 955850, 954125, 951617, 954124, 957951, 956576, 955846, 954123, 956577, 954139, 951610;
 
18) Lot: 950305;
 
19) Lots: 957933, 951228, 957934, 955144, 952998, 951230, 952998;
 
20) Lots: 952322, 948734, 952009, 957219, 923847
RECALLING FIRM/MANUFACTURER
by telephone on December 29, 2011. Firm initiated recall is ongoing.
REASON
The firm's internal audit resulted in discovery of manufacturing/processing deficiencies. There is evidence of rodent activity.
VOLUME OF PRODUCT IN COMMERCE
Approximately 16,888.7 pounds
DISTRIBUTION
UT, WY, ID, NV
 
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 Report, 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
Fludeoxyglucose F 18 Injection, 20-300mCi/mL, Diagnostic, IV, Multiple-Dose Vial, Rx only, NDC 52768-001-50
CODE
6509, Expiration Date: 6:15 pm on 27 December 2011
RECALLING FIRM/MANUFACTURER
Precision Nuclear of Virginia, Salem, VA 24153-6427
REASON FOR RECALL
Impurities/Degradation Product: out-of-specification (OOS) results for Acetonitrile, K222 and Radiochemical purity
 
FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white tablets each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak Dispensers of 28 Tablets each, Rx Only, NDC 24090-801-84. Recall # D-1188-2012;
 
2) Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets --- 21 white tablets, each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak Dispensers of 28 Tablets each, Rx Only, NDC 24090-961-84. Recall # D-1189-2012
CODE
1) Lot Expiration; E15678 08/31/2013; E15679 08/31/2013; E15686 08/31/2013; E15687 01/31/2014; E15690 01/31/2014; E15698 01/31/2014; E15700 02/28/2014; E80434 07/31/2013; E80438 08/31/2013; F36908 02/28/2014; F36909 02/28/2014; F43915 03/31/2014; F43926 03/31/2014; F43927 03/31/2014;
 
2) Lot Expiration; E15677 08/31/2013; E15704 01/31/2014; E15706 01/31/2014; E80440 08/31/2013; F16388 01/31/2014; F16390 02/28/2014; F22132 02/28/2014; F31330 02/28/2014; F36911 03/31/2014; F36913 03/31/2014; F43924 03/31/2014; F43925 03/31/2014; F43934 03/31/2014; F53238 03/31/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by press release issued on February 1, 2012. 
Manufacturer: Pfizer, Inc., Rouses Point, NY. Firm Initiated recall is ongoing.
REASON
Contraceptive Tablets Out of Sequence: some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.
VOLUME OF PRODUCT IN COMMERCE
171,928 Packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) 15% Minoxidil for Men, Enhanced with Azelaic 5%, Topical Hair Regrowth Formula, 2 fl oz 60 mL bottles. Recall # D-1190-2012;
 
2) 10% Minoxidil for Men, Enhanced with Azelaic 5%, Topical Hair Re-growth Formula, 2 fl oz 60 mL glass bottle. Recall # D-1191-2012;
 
3) 5% Minoxidil for Men, Enhanced with Azelaic 5% Topical Hair Regrowth Formula, 2 fl oz 60 mL glass bottle. Recall # D-1192-2012;
 
4) 3% Minoxidil for Women, Enhances with Azelaic 1.5%; Hair Regrowth Topical, 2 fl oz 60 mL glass bottles, Recall # D-1193-2012;
 
5) Hair Regrowth Shampoo Enhanced with Ketoconazole and Salicylic Acid, 6 fl oz. 180 mL, plastic bottle, Recall # D-1194-2012
CODE
1) All expiration dates up to Oct. 2013;
2) All expiration dates up to Oct. 2013;
3) All expiration dates up to Sept. 2014;
4) All expiration dates up to Nov. 2013;
5) All expiration dates up to Dec. 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perfect Image Solutions LLC, Roseville, CA, by press on January 19, 2012 and letters on January 20, 2012.
Manufacturer: Custom Manufacturing Corp, Medley, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: products are unapproved drugs.
VOLUME OF PRODUCT IN COMMERCE
109,000 units
DISTRIBUTION
Nationwide, Macau, Russia, Dubai, Hong Kong and Taiwan
___________________________________
PRODUCT
Azithromycin 250 mg tablets, 1 card x 6 Tablets, Rx only, NDC 0093-7146-18 (Teva Pharmaceuticals), A-S Product No. 5755-0. Recall # D-1198-2012
CODE
Lot 1318262, Exp 04/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: A-S Medication Solutions LLC, Libertyville, IL, by letters dated January 24, 2012 and telephone.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing
REASON
Labeling: Label with Incorrect Expiration Date.
VOLUME OF PRODUCT IN COMMERCE
720 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) TestaEdge Cream For Men, Homeopathic, packaged in 4-oz. jars, Paraben Free, NDC # 57520-0688-1, UPC Code 898849001001. Recall # D-1199-2012;
 
2) TestaEdge Cream For Women, Homeopathic, packaged in 4-oz. jars, Paraben Free, NDC # 57520-0907-1, UPC Code 898849001018. Recall # D-1200-2012;
 
3) Pain Relief Cream, Homeopathic, packaged in 4-oz jars, Paraben Free, NDC # 57520-0689-1, UPC Code 898849001025. Recall # D-1201-2012;
 
4) Libido Edge Labs Total GH Cream, Homeopathic, packaged in 4-oz. jars, Paraben free, NDC # 57520-0690-1, UPC Code 898849001278. Recall # D-1202-2012
CODE
1) Lot G7519;
2) Lot G7518;
3) Lot G7437;
4) Lot G7438
RECALLING FIRM/MANUFACTURER
Apotheca Inc, Woodbine, IA, by telephone on January 17, 2011 and e-mail and certified mail letters on January 20, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products:  presence of Enterobacter gergoviae and Pseudomonas monteilii/plecoglossicida.
VOLUME OF PRODUCT IN COMMERCE
3,490 Jars
DISTRIBUTION
OH
 
FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
CHLORHEXIDINE, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml), Gelato, Manufactured by: Deepak Products, LLC, Miami, FL -- NDC 068400-500-16 ----- ALSO LABELED AS CHLORHEXIDINE, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml), Gibson Healthcare, Distributed Exclusively by: Benco Dental, Pittsburgh, PA --- NDC 066975-500-16, and ORA-RINZ, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml) Manufactured for: Pearson Dental Supply Inc. Sylmar, CA 91342 USA, NDC 068400-155-16. Recall # D-1187-2012.
CODE
Lot #’s: 110226A, 110420F, 110509, 110721D, 110603D, 110721D, 110901, 111005A, 110420F, 110314E, 110622B, 110811, 110222A, 110222B, 110223, 110223A, 110223B, 110224, 110224A, 110224B, 110225B, 110225C, 110225D, 110225F, 110301B, 110301D, 110302B, 110302C, 110303A, 110303B, 110413C, 110413D, 110415B, 110414A, 110414B, 110414C, 110415, 110415A, 110425B,110425c, 110425D, 110426B, 110426C, 110426D, 110427B, 110427C, 110429C, 110606A, 110607B, 110607C, 110607D, 110622C, 110623, 110623B, 110623F, 110629B, 110629C, 110629D, 110630A, 110630B, 110630C, 110803A, 110805, 110805A, 110805B, 110808C, 110818A, 110823A, 110901
RECALLING FIRM/MANUFACTURER
Deepak Products, Inc., Miami, FL, by letters on December 2, 2011. Firm initiated recall is ongoing.
REASON
CGMP Deviations.
VOLUME OF PRODUCT IN COMMERCE
32,083 bottles
DISTRIBUTION
Nationwide, and El Salvador, Dominican Republic, and Honduras
___________________________________
PRODUCT
Prosed DS Tablets (Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, and Hyoscyamine Sulfate 0.12 mg), 100 count bottle, Rx Only, NDC 55566-8101-1. Recall # D-1195-2012
CODE
Lot # 101329 Exp Date 04/12; and Lot # 102285 Exp Date 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by letters on September 1, 2011.
Manufacturer: Contract Pharmacal Corp., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Subpotent (multiple ingredient drug): hyoscyamine sulfate component.
VOLUME OF PRODUCT IN COMMERCE
51,198 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Xanax, alprazolam tablets, USP, 0.5 mg, 100 Tablets, Rx only, NDC 0009-0055-01. Recall # D-1197-2012
CODE
Lot: C081196
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Us Pharmaceutical Group, New York, NY, by letters on January 17, 2012.
Manufacturing Firm 1: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Stability testing yielded an out-of-specification result for assay at the 36 month stability testing timepoint
VOLUME OF PRODUCT IN COMMERCE
36,129 bottles
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0443-12
CODE
Unit: W036311106953
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on October 6, 2011 and email on October 7, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0464-12
CODE
Units: W117011316737 Part A; W117011316737 Part B
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by letter on 10/17/2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0465-12
CODE
Unit: W038111221977
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Melbourne, FL, by facsimile on October 3, 2011.
Manufacturer: Florida's Blood Centers, Inc., Rockledge, FL. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0466-12
CODE
Unit: W117011320583W
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone and fax on 10/17/2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0467-12
CODE
Unit: W0907110088081
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by letter on October 26, 2011.  
Manufacturer: Blood Centers of the Pacific - Santa Rosa Center, Santa Rosa, CA. 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
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0471-12
CODE
Unit: W036810164860
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone on October 31, 2011 and by letter dated October 31, 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
Switzerland, FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0472-12;
2) Fresh Frozen Plasma. Recall # B-0473-12
CODE
1) and 2) Unit: W036811091200
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on October 31, 2011 and by letter dated October 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0474-12;
2) Red Blood Cells. Recall # B-0475-12
CODE
1) and 2) Unit: W036811142436
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone on October 25, 2011 and by letter dated October 25, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0477-12
CODE
Unit: W036809319362
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S FL, Inc., Lauderhill, FL, by telephone on September 16, 2011 and by letter dated September 16, 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
Switzerland, NY
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0479-12;
2) Cryoprecipitated AHF, Pooled. Recall # B-0481-12
CODE
1) Unit: W036810151637;
2) Unit: W036810801560
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on September 16, 2011 and by letter dated September 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
Source Plasma. Recall # B-0482-12 
CODE
Unit: LC0702393
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by facsimile on November 4, 2011 and by e-mail on December 9, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within one year of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0483-12;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0484-12
CODE
1) Unit: W088411547723;
2) Unit: W088411403959 (includes platelet unit W088411547723)
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, Hawaii, by e-mail on November 4, 2011 and by letter dated November 4, 2011. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Hawaii, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0520-12
CODE
Unit: W037911173836
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on October 31, 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
IA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0522-12;
2) Red Blood Cells. Recall # B-0523-12;
3) Platelets. Recall # B-0524-12
CODE
1) and 2) Units: 1160756; 1103330;
3) Unit: 1103330
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on October 21, 2011 and November 29, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
VT, VA, MN
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0525-12
CODE
Unit: W3769110004168
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on November 16, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0526-12
CODE
Unit: 3400123817
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Raleigh, NC, by facsimile on October 31, 2011 and November 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0444-12 
CODE
Unit: W036311106953
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on October 6, 2011 and email on October 7, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0446-12
CODE
Unit: 27FL54666
RECALLING FIRM/MANUFACTURER
American Red Cross Greater Alleghenies Region, Johnstown, PA, by letter on September 29, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-0461-12
CODE
Unit: W227011045013
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone and facsimile on November 30, 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
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0468-12
CODE
Unit: 18KS00427
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by electronic mail notification on September 28, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0469-12
CODE
W036311308198 (2 units)
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by telephone on October 3, 2011. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing for White Blood Cell count was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0470-12
CODE
Unit: W036810164860
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone on October 31, 2011 and by letter dated October 31, 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
Switzerland, FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0476-12
CODE
Unit: W036809385276
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Inc., Orlando, FL, by letter dated October 26, 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
Recovered Plasma. Recall # B-0478-12
CODE
Unit: W036809319362
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S FL, Inc., Lauderhill, FL, by telephone on September 16, 2011 and by letter dated September 16, 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
Switzerland, NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0480-12
CODE
Unit: W036810151637
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on September 16, 2011 and by letter dated September 16, 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
Switzerland, FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0519-12
CODE
Unit: W3038110110236
RECALLING FIRM/MANUFACTURER
Ochsner Health System Blood Bank, New Orleans, LA, by electronic mail on July 23, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0521-12
CODE
Unit: 1160756
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on October 21, 2011 and November 29, 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
VT, VA, MN
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves. Recall # Z-0712-2012
CODE
Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adenna Inc., Ontario, CA, by letter dated December 22, 2011.
Manufacturer: Tekmedic Sdn Bhd, Melaka, Malaysia. Firm initiated recall is ongoing.
REASON
The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
VOLUME OF PRODUCT IN COMMERCE
427 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Recall # Z-0825-2012
CODE
Lot Codes: 8SU203 EXPIRATION DATE: 12/31/2011, 8SU204 EXPIRATION DATE: 12/31/2011, 8SU205 EXPIRATION DATE: 12/31/2011, 09DU02013 EXPIRATION DATE: 04/30/2012, 09DU02014 EXPIRATION DATE: 04/30/2012, 09DU02022 EXPIRATION DATE: 04/30/2012, 09NU02011 EXPIRATION DATE: 10/31/2012, 09PU02011 EXPIRATION DATE: 11/30/2012, 09SU02001 EXPIRATION DATE: 12/31/2012, 09SU02007 EXPIRATION DATE: 12/31/2012, 10AU02013 EXPIRATION DATE: 01/31/2013, 10CU02001 EXPIRATION DATE: 03/31/2013, 10EU02010 EXPIRATION DATE: 05/31/2013, 10EU02017 EXPIRATION DATE: 05/31/2013, 10HU02013 EXPIRATION DATE: 06/30/2013, 10HU02014 EXPIRATION DATE: 06/30/2013, 10LU02001 EXPIRATION DATE: 09/30/2013, 10LU02013 EXPIRATION DATE: 09/30/2013, 10LU02014 EXPIRATION DATE: 09/30/2013, 10LU02015 EXPIRATION DATE: 09/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham MA, by telephone on December 27, 2011, and letter dated December 27, 2011.
Manufacturer: Fresenius Medical Care, North America, Ogden, UT. Firm initiated recall is ongoing.
REASON
Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak.
VOLUME OF PRODUCT IN COMMERCE
599,436 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Recall # Z-0869-2012
CODE
Serial Numbers: 400000 through 405499
RECALLING FIRM/MANUFACTURER
Steris Corporation Hopkins Facility, Mentor, OH, by letter dated December 8, 2011. Firm initiated recall is ongoing.
REASON
Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteria may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which will enable the SYSTEM 1E to handle a wider range of user facility water characteristics.
VOLUME OF PRODUCT IN COMMERCE
3,882 units
DISTRIBUTION
Nationwide, and Bahrain, Hong Kong, Japan and South Korea
___________________________________
PRODUCT
1) Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; The kit catalog numbers: PBVFLCAVJ, PCW1VPMUW, PE41TP55A, PE73EALUO, PE73MNLUM, PEDKEASTH, PEOCMEBL1, PEOCMEBLD, PEVFBHAVK, PEVFENAVH, PEVFHNAVJ, PEVNMJCHF, PG73HNLUL, PG73OTALUN, PGCGOTUI8, PGCGOTUII, PGVFGMAVM, PGVFLPAVC, PGVFMNAVG, PGVFOTAVD, PGVFTTAVK, PGVNGSCHJ, PLVFOTAVJ, PN21CYBIG, PN21CYBIH, PN41CY557, PN73CR11F, PN73SPLUT, PN73VPLUV, PNV2ALCPA, PNV2CY10Z, PNV2LM10R, PNV2OT10H, PNV2OTA10Q, PNVFLNAVK, PO73AALU1, PO73AALUR, PP69OHMLO, PUOCOT13J, PVV2CA10B, SBA13KDBSY, SBA23KTNCC, SBA23OPNCC, SBACGSTAHA, SCV11CACPR, SCV19OHCHX, SCV23MJNCH, SEN41TYCMC, SID21ACUHA, SIDCGISAUA, SNE11ALCPA, SNE11CR10F, SNE11LM10C, SNE11NMCPX, SNE14ACHHK, SNE14CRHHK, SNE14LLHHN, SNE21SHEGS, and SNE32CRSA7 contain one or more of the following listed components: a) Silastic Tubing, 0.062 ID x 0.032 Wall x 50 Ft, component C-602-285, vendor part number SFM3-2850; b) Silastic Tubing, 0.040 ID x 0.023 Wall x 50 Ft, component C-SFM3-2050, vendor part number SFM3-2050; c) Pathology Container with Lid, 8 oz., component 3701Z, vendor part number 3701; d) Silicone Tubing, 0.187 ID x 0.313 OD x 50 Ft., component C-31010SG, vendor part number 31010; Recall # Z-0871-2012;
 
2) Presource Custom Sterile Surgical and Procedure Kits; surgical trays; The kit catalog numbers kit catalog numbers ICU955327G, ICU955327H, and MAT330041C contain one or more of the following listed components: a) Cool Peri-Pad Self-Adhesive Absorbent Pad with Built-In Cold Pack, component C-CP23, vendor part number CP23; b) Giraffe Disposable Skin Temperature Probe, vendor part number 6600-0873-700. Recall # Z-0872-2012
CODE
1) and 2) All recent lots
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by letter dated December 12, 2011. Firm initiated recall is ongoing.
REASON
Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product
VOLUME OF PRODUCT IN COMMERCE
7,213 each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol. Accessory to endoscopy kits used to charge/recharge lithium ion batteries. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set. Recall # Z-0928-2012;
 
Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Accessory to endoscopy kits used to charge/recharge lithium ion batteries. Products which include this item are VISION SCIENCES CAT. No. ITEM Description; 07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*; 07-3053 BLS Kit; 07-3053X BLS Kit*; 07-3052 Rechargeable Batteries, Lithium-Ion; 07-3052X Rechargeable Batteries, Lithium-Ion*; 02-2602 ENT-3000 Scope (Standard Set); 02-2602-IN ENT-3000 Scope (Standard Set)*; 02-2602X ENT-3000 Scope (Standard Set)*; 02-4201 ENT-4000 Portable Set; 02-4201X ENT-4000 Portable Set. Recall # Z-0929-2012
CODE
All units
RECALLING FIRM/MANUFACTURER
Vision-Sciences, Inc. Orangeburg, NY, by letter dated December 27, 2011. Firm initiated recall is ongoing.
REASON
Potential for over-heating and possible burning of the lithium-ion batteries being charged.
VOLUME OF PRODUCT IN COMMERCE
1618 chargers, 3628 batteries
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube. Catalogue number: 0210-22. Recall # Z-0938-2012
CODE
Lot number: AA1129E02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark Corp., Roswell, GA, by letter on December 21, 2011. Manufacturer: Avent S.A. De C.V, Nogales Sonora, Mexico. Firm initiated recall is ongoing.
REASON
The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port.
VOLUME OF PRODUCT IN COMMERCE
50 devices
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
DRAD-3000E: Radrex-i X-Ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***" Recall # Z-0941-2012
CODE
Serial numbers of the following: U2A0892009, U2A08X2010, U2A08X2011, U2A08Y2012, U2A08Z2013, U2A08Z2014, U2A0912015, U2A0912016, U2A0922017, U2A0942019, U2A0942020, U2A0942021, U2A0952022, U2A0952023, U2A0972024, U2A0972025, U2A0982026, U2B09X2027, U2B09Y2028, U2B09Y2029, U2B09Z2030, U2B1042031, U2B1042032, U2C1052033, U2C1062034, U4A0982001, U4A0982002, U4A0992003, U4A09X2004, U4A09Z2005, U4A09Z2006, U4A09Z2007, U4A1022009, U4B1022010, U4B1032011, U4B1052012, U4B1052013, U4B1062014, U6A0972001 and U4B1012008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on December 29, 2011. Firm initiated recall is ongoing.
REASON
It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. Recall # Z-0964-2012
CODE
ROM versions prior to 3.40
RECALLING FIRM/MANUFACTURER
Alere San Diego, San Diego, CA, by letters in November, 2010. Firm initiated recall is ongoing.
REASON
Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
VOLUME OF PRODUCT IN COMMERCE
22,000 meters
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
GE LOGIQ P6 Ultrasound System. Recall # V-027-2012
CODE
Serial Number 133455SU6 148046SU6 153220SU9 136034SU6 136853SU9 144433SU0 136032SU0 134903SU4 151085SU8 161800SU8 161801SU6
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated December 23, 2011.
Manufacturer: GE Ultrasound Korea Co., Ltd. Kyunggi-Do, Korea, Republic Of (South). Firm initiated recall is ongoing..
REASON
GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.
VOLUME OF PRODUCT IN COMMERCE
2270 (11 for veterinary use)
DISTRIBUTION
VA, TX, KY, SC, MA, IA
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
1) Bright Meadows All Purpose Goat feed Medicated, 100 lb bags. Recall # V-028-2012;
2) Bright Meadows 16% Calf feed Grower Medicated, 100 lb bags. Recall # V-029-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Vonada Enterprises, Mill Hall, PA, by visits beginning December 28, 2011. Firm initiated recall is ongoing.
REASON
Feed labeled as medicated feed was distributed, however, the feed was not medicated. Medicated feed labels were applied by mistake.
VOLUME OF PRODUCT IN COMMERCE
1 ton
DISTRIBUTION
PA
___________________________________
PRODUCT
Sacox 60, Brand of salinomycin sodium Type A Medicated Article, containing salinomycin equivalent to 60 grams salinomycin sodium activity per pound, packaged in 50-lb. bags, ANADA 200-075. Recall # V-030-2012
CODE
Lot BSB394, Exp. December 2012
RECALLING FIRM/MANUFACTURER
Huvepharma Inc., Saint Louis, MO, by telephone on December 29, 2011. Firm Initiated recall is complete.
REASON
Product tested OOS (high) and was inadvertently distributed.
VOLUME OF PRODUCT IN COMMERCE
160/50-lb. bags
DISTRIBUTION
GA, LA
 
END OF ENFORCEMENT REPORT FOR FEBRUARY 8, 2012.
 
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