December 5, 2001 01-48
RECALLS AND FIELD CORRECTIONS: FOODS CLASS I
_______________________ PRODUCT Advance brand Dried Sweet Potato packed in flexible plastic bags, net wt. 6 oz. PRODUCT of China, Recall # F-063-2. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Ho's Trading Inc. Brooklyn, NY, by letter on 5/04/00. Manufacturer: Zhao Wu Chen Guangdong, China. Recall resulted from inspection and analysis by the New York State Department of Agriculture and Markets. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 44 cases (100 - 6 oz. packages per case) were distributed. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS II
_______________________ PRODUCT Equate Allergy Medication Decongestant Caplets in 24 caplet blister cartons. The product is an OTC product containing Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg., Capsule-Shaped tablets, Recall # D-040-2. CODE Lot No. 1GB0825, 1GB1041, 1GB1042. RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner Health Products, Inc. Carson, CA. Manufacturer: Leiner Health Products, Inc. Fort Mill, SC. Firm initiated recall is ongoing. REASON Misbranding; directions for use may lead to a doubling of the dosage. VOLUME OF PRODUCT IN COMMERCE 45,504/24 caplet cartons. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II
_______________________ PRODUCT Red Blood Cells, Recall # B-0315-2. CODE Unit C42199. RECALLING FIRM/MANUFACTURER Southeastern Community Blood Center, Tallahassee, FL, by letter on November 11, 1997. 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 GA. _______________________ PRODUCT Diagnostic Leukocytes, Recall # B-0321-2. CODE Unit UA15590. RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc., Memphis, TN, by telephone and email on July 21, 2000. Firm initiated recall is complete. REASON Blood product, which tested RPR reactive for syphilis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Source Plasma, Recall B-0323-2. CODE Unit A00443370. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Hoover, AL, by fax dated July 6, 2000. Firm initiated recall is complete. REASON Blood product, incorrectly for hepatitis B surface antigen(HbsAg), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Platelets, Pheresis, Recall # B-0324-2. CODE Unit 02P50305. RECALLING FIRM/MANUFACTURER The American National Red Cross, Wichita, KS, by telephone on June 30, 2000, and by letter dated July 14, 2000. Firm initiated recall is complete. REASON Blood product, incorrectly labeled as leukoreduced, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KS. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0326-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0327-2; c) Platelets, Recall # B-0328-2. CODE a) Unit 1742247; b) Unit 1794288; c) Unit 1794288. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 26, 2001. 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 3 units. DISTRIBUTION KY. _______________________ PRODUCT Platelets Pheresis, Recall # B-0329-2. CODE Unit 02P48721. RECALLING FIRM/MANUFACTURER The American National Red Cross, Wichita, KS, by letter dated May 11, 2001. 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 KS. _______________________ PRODUCT Red Blood Cells, Leukocytes , Recall # B-0330-2. CODE Unit 02FC75813, 02FC73354, 02FC70562, and 02FC67087. RECALLING FIRM/MANUFACTURER The American National Red Cross, Wichita, KS, by letter dated August 7, 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 KS. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0334-2. CODE Units 1737956, 1741856. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, KY, by facsimile dated August 2, 2001. Firm initiated recall is complete. REASON Blood products, which may have been incorrectly tested for unexpected antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION KY. _______________________ PRODUCT Source Plasma , Recall # B-0337-2. CODE Units T-12787-097, T-12710-097, T-12481-097, T-12416-097, T- 11827-097 T-11741-097, T-11570-097, T-11502-097, T-11357-097, T-11291-097 T-11094-097, T-11032-097, T-10914-097, T-10847-097, T-10177-097 T-09985-097, T-09844-097, T-09543-097, T-09470-097, T-09254-097 T-09217-097, T-08807-097, T-08550-097, T-08443-097, T-08233-097 T-08140-097, T-07961-097, T-07880-097, T-07686-097, T-07611-097 T-07369-097, T-06962-097, G-90994-097, G-90751-097, G-90182-097 G-89932-097, G-89377-097, G-89129-097, G-88022-097, G-87701-097 G-87048-097, G-86672-097, G-85926-097, G-85494-097, G-84844-097 G-84449-097, G-83092-097, G-82827-097, G-82031-097, G-81782-097 C-32744-097, C-32687-097, C-32670-097, C-32617-097, C-32597-097 C-32530-097, C-32492-097, C-32439-097. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by letter dated June 5, 2000. Manufacturer: Alpha Therapeutic Corporation, San Diego, CA. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 58 Units. DISTRIBUTION MD and Spain. _______________________ PRODUCT Platelets Pheresis, Recall #B-0349-2. CODE Units 0055517, 0055550, 0056230, 0056244, 0056343, 0056346, 0056396, 0056842, 0056847, 0056964, 0056967, 0056982, 0056993, 0057000, 0057003, 0057006, 0057008, 0057034, 0057181, 0057182, 0057187, 0057190, 0057213, 0057196, 0057202, 0058098, 0058114, 0058133, 0058789, 0058792, 0058814, 3809306, 3809308, 3809318, 3809335, 3862248, 3862630, 3873321, 3873328, 3873372, 3873690, 3874104, 3874105, 3874137, 3874138, 3874139, and 3852664; (the following unit numbers were distributed as two split units) 0055514, 0055527, 0055528, 0055579, 0056239, 0056362, 0056368, 0056370, 0056373, 0056401, 0056624, 0056662, 0056873, 0056965, 0057004, 0057026, 0057032, 0057049, 0057191, 0057192, 0057200, 0057230, 0058827, 3809323, 3809328, 3844324, 3862621, 3862632, 3873318, 3873325, 3873329, 3873362, 3873368, 3873374, 3874119, 3874124, 3874134, and 3874135. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters dated May 26, 1999, June 4, 1999, August 30, 1999, and July 11, 2001. Manufacturer: Blood Systems, Inc., Lubbock, TX. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 123 units. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-0350-2. CODE Units 0150729, 0011747, 0268889. RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center, Inc., New York, NY, recall by letter dated September 10, 2001. Manufacturer: Stichting Sanguine Bloodvoorziening/CLB, Amsterdam, Netherlands. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from ineligible donors based on: 1) previous repeatedly reactive testing for the antibody to hepatitis C virus (anti-HCV); or 2) the application of a tattoo within the previous 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NY and NJ. _______________________ PRODUCT Red Blood Cells, Recall # B-0351-2. CODE Units 0303126, 0319174, 0313640, 0302536, 0329989, 0308413, 0308737, 0310730, 0313982, 0306639, 9615611, and 0309772. RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center, Inc., New York, NY, by letters dated July 18, 19, and 20, 2000. Manufacturer: Stichting Sanguine Bloodvoorziening/CLB, Amsterdam, Netherlands. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but were collected from ineligible donors based on previous reactive testing for the antibody to hepatitis C virus (anti-HCV), the antibody to human immunodeficiency virus (anti- HIV), or syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 12 units. DISTRIBUTION NY and NJ. _______________________ PRODUCT Red Blood Cells, Recall # B-0352-2; Platelets, Recall # B-0353-2. CODE Unit 01LC30728; Unit 01LC30728. RECALLING FIRM/MANUFACTURER The American National Red Cross, West Henrietta, NY, by letter dated October 30, 2001. REASON Blood product, that tested negative for Cytomegalovirus (CMV), but were collected from a donor who previously tested CMV positive, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Source Plasma, Recall # B-0354-2. CODE Units LP-21937, LP-21695, LP-15834, and LV-20878. RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid Biological Corporation, Van Nuys, CA, by letter dated April 12, 2000. Manufacturer: Pyramid Biological Corporation, Las Vegas, NV, Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION Germany and Austria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS III
_______________________ PRODUCT Fresh Frozen Plasma , Recall # B-0316-2. CODE Unit 084GS13208. RECALLING FIRM/MANUFACTURER The American National Red Cross, Oakland, CA, by letter dated October 13, 1999. Firm initiated recall is complete. REASON Blood product, whose collection time exceeded the maximum time in the firm’s standard operating procedures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0317-2. CODE Unit 5404617. RECALLING FIRM/MANUFACTURER Southeastern Community Blood Center, Tallahassee, FL, by telephone on or about May 3, 1998. Firm initiated recall is complete. REASON Unlicensed blood product was distributed interstate. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0325-2. CODE Unit 02FG92721. RECALLING FIRM/MANUFACTURER The American National Red Cross, Wichita, KS, by telephone on July 19, 2000, and by letter dated July 27, 2000. Firm initiated recall is complete. REASON Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KS. _______________________ PRODUCT Red Blood Cells (183 units), Recall # B-0331-2. CODES Units 9609957, 9609960, 9609961, 9609962, 9609964, 9609965, 9609966, 9609967, 9609968, 9609969, 9609970, 9609971, 9609972, 9609973, 9609974, 9609975, 9609977, 9609978, 9609979, 9609980, 9609983, 9609984, 9609985, 9609988, 9609989, 9609990, 9609991, 9609992, 9609993, 9609996, 9609997, 9610000, 9611206, 9611207, 9611209, 9611210, 9611211, 9611212, 9611213, 9611215, 9611216, 9611217, 9611218, 9611220, 9611221, 9611222, 9611223, 9611224, 9611225, 9611226, 9611227, 9611228, 9611229, 9611232, 9611233, 9611234, 9611235, 9611237, 9611238, 9611239, 9611240, 9611241, 9611242, 9611243, 9611245, 9611246, 9611247, 9611248, 9611249, 9611250, 9611252, 9611256, 9611257, 9611258, 9611259, 9611261, 9611262, 9611263, 9611264, 9613001, 9613004, 9613006, 9613007, 9613008, 9613009, 9613010, 9613012, 9613013, 9613014, 9613015, 9613016, 9613017, 9613018, 9613019, 9613020, 9613021, 9613024, 9613025, 9613028, 9613031, 9613032, 9613033, 9613034, 9613036, 9613038, 9613039, 9613040, 9613041, 9613042, 9613045, 9613046, 9613047, 9613048, 9613049, 9613050, 9613051, 9613052, 9613053, 9613054, 9613055, 9613056, 9613057, 9613058, 9613060, 9613062, 9613063, 9613064, 9613907, 9613908, 9613909, 9613910, 9613911, 9613912, 9613914, 9613915, 9613916, 9613917, 9613918, 9613920, 9613921, 9613922, 9613923, 9613925, 9613926, 9613927, 9613936, 9613938, 9613939, 9613940, 9613941, 9613943, 9613947, 9613948, 9613953, 9613954, 9613955, 9613956, 9613957, 9613958, 9613959, 9613960, 9613961, 9613962, 9613963, 9613964, 9616288, 9616289, 9616291, 9616294, 9616297, 9616300, 9616301, 9616302, 9616305, 9616308, 9616310, 9616312, 9616313, 9616319, 9616320, 9616322, 9616325, and 9616326. RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY, by letter dated May 22, 2000. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 183 units. DISTRIBUTION NY and NJ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0332-2; b) Platelets, Recall # B-0333-2; CODE a) Units 1742066, 1732834, 1746885, 1742046, 1737990, 1748134, 1737956, 1751321, 1743575, 1751459, 1734953, 1752154, 1748226, 1741856; b) Units 1742066, 1751459, 1734953, 1741856. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by facsimile dated August 2, 2001. Firm initiated recall is complete. REASON Blood product, which may have been incorrectly tested for unexpected antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 18 units. DISTRIBUTION KY. _______________________ PRODUCT Source Plasma, Recall # B-0346-2. CODE Unit 43275632. RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by letter on October 30, 2000. Firm initiated recall is complete. REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results for the donor of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0347-2. CODE Unit 41327593. RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by letter on October 25, 2000. Firm initiated recall is complete. REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results for the donor of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0348-2. CODE Unit 43277377. RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by letter on October 30, 2000. Firm initiated recall is complete. REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results for the donor of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
_______________________ PRODUCT Adult and Pediatric Heated Wire Breathing Circuits: a) Recall # Z-0324-2; b) Recall # Z-0325-2. CODE a) Adult Heated Wire Breathing Circuits: 780-19; 780-20; 780-31; 780-32; 780-33; 780-34; 780-35; 780-36; 780-51; 780-52; 790-32; 790-52. b) Pediatric Heated Wire Breathing Circuits: 780-23; 780-24; 780-25; 780-30. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care, Inc., Temecula, CA, by letter on October 12, 2001. Firm initiated recall is ongoing. REASON Risk of overheating and fire. VOLUME OF PRODUCT IN COMMERCE 892,772. DISTRIBUTION Nationwide and worldwide. _______________________ PRODUCT AEROSET (brand) Uric Acid, product list number, part or model: LN 07D76-01. All lots (inclusive lot numbers detailed later), Recall # Z-0326-2. CODE All lots and codes of Uric Acid for use in Aeroset brand. 67058HW00; 64093HW00; 69086HW00; 66056HW00; 76043HW00; 79015HW00. RECALLING FIRM/MANUFACTURER Abbott laboratories, Inc., South Pasadena, CA, by letter dated October 9, 2001. Firm initiated recall is ongoing. REASON Discoloration -- calibration must be done with cartridge change. VOLUME OF PRODUCT IN COMMERCE 1,545. DISTRIBUTION Nationwide and worldwide. _______________________ PRODUCT Brand Name: BD 3ml Syringe with BD Twinpak, BD 10ml Syringe with BD Twinpak. Common Name: Piston syringe with blunt plastic cannula and metal Cannula, Recall # Z-0327-2. CODE Catalog No. 303391 and 303393, Lot Numbers: 1149658, 1198494 and 1127987. RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & CO., Franklin Lakes, NJ, by letter on 9/21/2001. Manufacturer: Becton Dickinson Consumer Products, Holdredge, NE. Firm initiated recall is ongoing. REASON Improperly sealed unit packages VOLUME OF PRODUCT IN COMMERCE 1,023,000 units. DISTRIBUTION Nationwide. _______________________ PRODUCT a) AEROSET Aspartate Aminiotransferase (AST) Part Number LN 07D81-01, Recall # Z-0328-2; b) AEROSET Alanine Aminotransferase (ALT) Part number LN 07D56-01, Recall # Z-0329-2. CODE All products, Aeroset Clinical Chemistry Analyzer. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA, by letter dated October 29, 2001. Firm initiated recall is ongoing. REASON Failure to exhibit Linear Low Flag upon substrate depletion condition. VOLUME OF PRODUCT IN COMMERCE 493. DISTRIBUTION Nationwide and worldwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I
_______________________ PRODUCT Premium Pig Ears, 100 CT, Recall # V-001-2. CODE 0235AB, 0236AB, 0239AB, 0242AB, 0243AB. RECALLING FIRM/MANUFACTURER Recalling firm: Pet Magic, Inc., Detroit, MI, by telephone on 9/21/01. Manufacturer: 3 Kuz Foods, Inc., QC, CA. FDA initiated recall is ongoing. REASON Product is contaminated with salmonella. VOLUME OF PRODUCT IN COMMERCE 1,344 cases (100 pieces/case). DISTRIBUTION IL, MI, OH.END OF ENFORCEMENT REPORT FOR DECEMBER 5, 2001. ###
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