January 22, 2003
03-04
_____________________________
PRODUCT
Frozen Raw Salad Shrimp in plastic package, net wt. 16 oz. (454 g). Product of China. Recall # F-153-3.
Product further packaged into white cardboard cases - 24 products per case. Net. Wt. 24 lbs (10.89 kg).
The UPC # is 75391-90046.
CODE
Cases may contain either freezer lot code - #508598 or # 45482.
Cases may also contain packer stickers - BSF JAX 9376.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beaver Street Fisheries, Jacksonville, FL, by telephone July 12 - 18, 2002.
Manufacturer: Hubei Jingmen Petrochemical Int'l Trading Co. Hubei, China. State initiated recall is complete.
REASON
Shrimp is contaminated with chloramphenicol.
VOLUME OF PRODUCT IN COMMERCE
436 cases/11,136 lbs.
DISTRIBUTION
TX and FL.
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PRODUCT
a) CHENG KANG brand RARE SOYBEAN MILK, packed in a
flexible plastic bottle, 350 cc. Recall # F-154-3;
b) ZHENG KANG brand EGG SOYBEAN MILK, packed in a flexible
plastic bottle, 350 ml. Recall # F-155-3;
c) ZHENG KANG brand STRAWBERRY SOYBEAN MILK, packed in a
flexible plastic bottle, 350 ml. Recall 3 F-156-3.
CODE
Barcode # 4 711609 000020.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hadson Toko Trading Co., Inc., Maspeth, NY, by letter on August 7, 2002.
Manufacturer: Chang Kang Food Co. Shin Wo Town, Taoyuan Hsien. FDA initiated recall is complete.
REASON
Products were manufactured under conditions whereby they may have been rendered injurious to health in that they are low-acid products for which the manufacturer has not registered or filed a scheduled process.
VOLUME OF PRODUCT IN COMMERCE
a) 1720 cartons;
b) 37 cartons;
c) 36 cartons were distributed.
There are 24 bottles per carton.
DISTRIBUTION
a) NY, NJ, PA, CT, MA, MI, OH, IL, MD, VA, GA, FL;
b) 7 Asian markets in NY, NJ, MD, OH;
c) 9 Asian markets in NY, NJ, MD, OH.
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PRODUCT
Fluoxetine Capsules USP, 20 mg, 500 and 1000 count bottles,
Rx only. Recall # D-061-3.
CODE
Lot 105458, Exp. 2/2004, 500 Count---NDC #00172-4356-70
Lot 104926, Exp. 2/2004, 1000 Count--NDC #00172-4356-80.
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Northvale, NJ, by letters on July 16, 2002. Firm initiated recall is ongoing.
REASON
Product exceeded specification for impurity level (1 month stability).
VOLUME OF PRODUCT IN COMMERCE
2991 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
______________________
PRODUCT
a) Premphase Tablets, (conjugated estrogens 0.625mg and
medroxyprogesterone 5mg) dial dispenser containing 28
tablets, Rx only. Recall # D-067-3;
b) Premarin Tablets (conjugated estrogens) 0.625 mg, Rx
only, unit dose packages of 100 (NDC 0046-0867-99),
bottles of 100 (NDC 0046-0867-81) and bottles of 5000
(NDC 0046-0867-95). Recall # D-068-3.
CODE
a) Lot 9001385, Exp 2/2003; Lot 9001386, Exp 2/2003
b) Lot 9001216, Exp 5/03; Lot 9000986, Exp 5/05;
Lot 9000846, Exp 5/05.
RECALLING FIRM/MANUFACTURER
A.H. Robins, Richmond, VA, by letter dated 11/18/02. Firm initiated recall is ongoing.
REASON
Dissolution; failure to meet specifications at the 24 month/2-hour timepoint.
VOLUME OF PRODUCT IN COMMERCE
a) Premphase - 41,220 units
b) Premarin - 198,676 units.
DISTRIBUTION
Nationwide.
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PRODUCT
Clemastine Fumarate Syrup, 0.5mg/5mL, Each teaspoonful (5mL) contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg) and alcohol 5.5%, 4 fluid ounces (118 mL) bottles, Rx only. Recall # D-108-3.
CODE
Lot number 1A950, exp. 02 2003.
RECALLING FIRM/MANUFACTURER
Novex Pharma, Richmond Hill, CA, by letter on November 19, 2002. Firm initiated recall is ongoing.
REASON
Degradation; product exceeds specification at 18 month timepoint.
VOLUME OF PRODUCT IN COMMERCE
2,083 bottles.
DISTRIBUTION
Nationwide.
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0332-3.
CODE
Unit FW29887.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on May 24, 2002 and by letter dated May 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0333-3.
CODE
Units FR37416, FR43796.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone and letter dated March 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0350-3.
CODE
Unit FQ36070.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, WI, by telephone and letter dated March 15, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0361-3;
b) Platelets, Recall # B-0362-3.
CODE
a) Units LP43896, GR27676, T92618;
b) Units T92618, GR27676 - Platelet Pool ID # - P21524.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc.,Milwaukee, WI, by telephone on April 25, 2002 and by letter dated April 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
WI.
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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0363-3;
b) Platelets, Pooled, Recall # B-0364-3;
CODE
a) Unit LC11016;
b) Unit LC11016 - Pooled Platelet ID # - P21513.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, WI, by telephone on March 8 and 13, 2002 and by letter dated March 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.
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PRODUCT
Source Plasma, Recall # B0390-3.
CODE
Units 01OWIB7802, 01OWIB8230, 01OWIB8235, 01OWIB8298, 01OWIB8579, 01OWIB8619, 01OWIB9103, 01OWIB9163, 01OWIB9169, 01OWIB9214, 01OWIB9363, 01OWIB9447, 01OWIB9599, 01OWIB9607, 01OWIB9630, 01OWIB9637, 01OWIB9701, 01OWIB9784, 01OWIC0503 01OWIC0513, 01OWIC0529, 01OWIC0530, 01OWIC0541, 01OWIC0549, 01OWIC0569, 01OWIC0582, 01OWIC0956, 01OWIC1076, 01OWIC1147, 01OWIC1142, 01OWIC1185, 01OWIC1202, 01OWIC1209, 01OWIC1383, 01OWIC1531, 01OWIC1520, 01OWIC1685, 01OWIC1954, 01OWIC2029, 01OWIC2517, 01OWIC2520, 01OWIC2547, 01OWIB8353, 01OWIC2632, 01OWIC2647, 01OWIC2809, 01OWIC2817, 01OWIC2887, 01OWIC2888, 01OWIC2902, 01OWIC2922, 01OWIC3216, 01OWIC3297, 01OWIC3126, 01OWIC1780.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax dated July 6, 2001.
Manufacturer: Community Bio-Resources, Inc., Oshkosh, WI. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not questioned regarding their travel to Africa, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units.
DISTRIBUTION
MI.
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PRODUCT
a) Red Blood Cells, Recall # B-0393-3;
b) Recovered Plasma, Recall B-0394-3.
CODE
a) and b) Unit 0872821.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, MN, by letter dated August 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a previous dura mater transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MN.
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PRODUCT
Red Blood Cells, Recall # B-414-3.
CODE
Unit C53064.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on September 16, 2002 and by letter dated October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0415-3.
CODE
Units 6669310 (products A and B), 666909 (products A and B).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by letter dated December 27, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.
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PRODUCT
Red Blood Cells, Recall # B-418-3.
CODE
Unit FT95463.
RECALLING FIRM/MANUFACTURER
Inova Health System, Annandale, VA, by letter dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Source Plasma, Recall # B-413-3.
CODE
Unit MSN001811.
RECALLING FIRM/MANUFACTURER
American Plasma, Inc., Mesa, AZ, by fax dated May 20, 2002. Firm initiated recall
is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
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PRODUCT
Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag. Recall # Z-316/318-3.
CODE
Drop Hooks are components of the wheelchair seat cushions coded as XLPD1516 XLPD1616 XLPD1618 XLPD1816 XLPD1717 XLPD1818 XLPI1516 XLPI1616 XLPI1816 XLPI1717 XLPI1818 XD... followed by one or more of the following, listed in product number: IDS, 05D, 1D, and 15D
RECALLING FIRM/MANUFACTURER
Action Products Incorporated, Hagerstown, MD, by letter on May 14, 2002. Firm initiated recall is complete.
REASON
Wheelchair seat component is defective.
VOLUME OF PRODUCT IN COMMERCE
73 sets.
DISTRIBUTION
LA, IN and MA.
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PRODUCT
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological
media plates. Catalog # 221267. Recall # Z-0345-3.
CODE
Lots: 2213201 EXP 11/25/02 2213211 EXP 11/26/02 2261524 EXP 1/14/02 2246310
EXP 1/1/03 2261552 EXP 1/15/03 2276445 EXP 1/29/03.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by fax on November 18, 2002. Firm initiated
recall is ongoing.
REASON
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus
species.
VOLUME OF PRODUCT IN COMMERCE
6422 cartons/100 plates per carton.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01. Recall # Z-405-3.
CODE
049007 and 041599.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on December 16, 2002. Firm initiated recall is ongoing.
REASON
Mislabeling.
VOLUME OF PRODUCT IN COMMERCE
Specified.
DISTRIBUTION
Nationwide and Australia, Canada.
END OF ENFORCEMENT REPORT FOR JANUARY 22, 2003
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