August 7, 2002 02-31
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Avalanche Cafe Java Ice Cream, half-gallon containers. Recall # F-712-2. CODE All lot numbers. RECALLING FIRM/MANUFACTURER Galliker Dairy Company, Johnstown, PA, by press release on June 14, 2002. Firm initiated recall is complete. REASON The product contained undeclared walnuts. VOLUME OF PRODUCT IN COMMERCE 5984 units. DISTRIBUTION MD, NY, NJ, OH, PA, VA, VT, and WV. _______________________ PRODUCT Don Berto's Old Fashioned Tomato Pie. The product is packaged on 9 x 12 inch styrofoam plate and shrink wrapped; each pie is approximately 1 lb. The product is shipped 20 pies per case or individually. Recall # F-713- 2. CODE Products manufactured prior to 7/11/02. RECALLING FIRM/MANUFACTURER Don Berto's Baking Company, Philadelphia, PA, by telephone on July 11, 2002. FDA initiated recall is complete. REASON The product contained undeclared milk ingredients. VOLUME OF PRODUCT IN COMMERCE 4186 pies. DISTRIBUTION PA, NJ, DE, and MD. _______________________ PRODUCT Products involved: 1) Small Dried Shrimp. Recall # F-714-2. a)Lisy Corp. brand Small Dried Shrimp, 705 Net Wt. .5 oz 14 GR. LISY CORP., Miami, FL. b)Lisy Corp brand Small Dried Shrimp, 706 Net Wt. 1.5 oz 43 GR. 2) Salsa Dried Shrimp. Recall # F-715-2. a)Lisy Corp brand Salsa Dried Shrimp 708 Net Wt .75 OZ. 21 GR. b)Lisy Corp brand Salsa Dried Shrimp, .5 OZ. 14 GR. 710 3) Lisy Corp brand Lemon & Natural Shrimp, .5 OZ 709. Recall # F- 716-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Lisy Corp., Miami, FL, by letter on April 11, 2002. Manufacturer: American Link Corp., Gardena, CA. Firm initiated recall is complete. REASON The products contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 98,160 bags. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Bottled drinking water, packaged in 12 packs of 20 ounce plastic PET bottles. Recall # F-718-2. CODE X May 0304SO and/or May 030206:05. RECALLING FIRM/MANUFACTURER Recalling Firm: Cott Corporation, Toronto, ON, by telephone on May 31, 2002. Manufacturer: Southern Bottled Water Company, Anniston, AL. Firm initiated recall is complete. REASON Bottled drinking water contains excessive amounts of chlorine. VOLUME OF PRODUCT IN COMMERCE 13,952 cases (12/case). DISTRIBUTION FL, TX, SC, GA, AR, and LA. _______________________ PRODUCT Singing Bird brand Bamboo Shoot Strips in 1 pound and 1.5 pound plastic jars. Recall # F-719-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Anhing Corporation, Los Angeles, CA, by letter dated July 2, 2002. State initiated recall is ongoing. REASON Bamboo shoot strips contain undeclared sulfites (237 ppm). VOLUME OF PRODUCT IN COMMERCE Not determined. DISTRIBUTION Nationwide. _______________________ PRODUCT La Monica brand Chopped Clams, in 6.5 oz. can. Recall # F-720-2. CODE Can Code: CMFA C271C. RECALLING FIRM/MANUFACTURER Cape May Foods, Inc., Burleigh, NJ, by telephone, fax and letter beginning January 10, 2002. Firm initiated recall is complete. REASON Canned clams were underprocessed, and may contain botulinum toxin. VOLUME OF PRODUCT IN COMMERCE 469 cases/24 cans per case. DISTRIBUTION NY, NJ, OH, FL, MO and TX. _______________________ PRODUCT Wylwood Select Fancy Cut Green Spears Asparagus in 15 ounce cans. Recall # F-721-2. CODE Can code: ASPC 126144-11. RECALLING FIRM/MANUFACTURER Recalling Firm: Mason County Fruit Packers, Ludington, MI, by product removal notification dated February 7, 2002. Manufacturer: Mason County Fruit Packers, Hart, MI. Firm initiated recall is complete. REASON Canned asparagus was underprocessed and may contain botulinum toxin. VOLUME OF PRODUCT IN COMMERCE 255 cases/24 cans per case; 300 size cans. DISTRIBUTION IN, KY, TN, VA and WV.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT YOO HOO Light Chocolate Drink in 9 oz. glass bottles. Recall # F-705-2. CODE Codes 208081A and 207101A printed on the bottom of each bottle. The code also contains additional 4 numbers at the end of the code, which represent production time. RECALLING FIRM/MANUFACTURER Recalling Firm: Yoo Hoo Chocolate Beverage Corp., White Plains, NY, by telephone on March 8 to 12, 2002. Manufacturer: Yoo Hoo Chocolate Beverage Corp., Hialeah, FL. Firm initiated recall is complete. REASON The product is spoiled. VOLUME OF PRODUCT IN COMMERCE 7,664 cases. DISTRIBUTION NC, GA, FL, AL AND SC. _______________________ PRODUCT Bottled Spring Water labeled in part: AMERICAN FARE Premium WATER QUALITY DRINKING WATER***.5L 16.9 FL OZ (1 PT 0.9 FL OZ)*** Product packaged in 4X3 cardboard carton labeled as "AMERICAN FARE Premium WATER QUALITY DRINKING WATER 12-.5 LITER BOTTLES (6L)/12-16.9 FL OZ BOTTLES (202.8 FL OZ)***." Carton shrink wrapped with clear plastic. Recall # F-706-2. CODE Production date code "12/26/01." RECALLING FIRM/MANUFACTURER Glacier Clear L.P., Orange Springs, FL, by telephone on April 4, 2002. Firm initiated recall is complete. REASON The product was contaminated with particulate matter. VOLUME OF PRODUCT IN COMMERCE 3997 Cases (12 bottles per case). DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Levothroid Tablets (levothyroxine sodium tablets, USP), 100 mcg., 100- tablet bottles, Rx only. NDC #0456-0323-01. Recall # D-362-2. CODE Lot #16828, Exp. Aug 02, and Lot #17145, Exp. Sep 02. RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letter and fax July 15, 2002. Manufacturer: Forest Pharmaceuticals, Inc, Cincinnati, OH. Firm initiated recall is ongoing. REASON Stability; low potency prior to labeled expiration date from manufacturer (Forest). VOLUME OF PRODUCT IN COMMERCE 1,006 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT RA SPES Capsules, Joint and Tendon Formula, 30 Capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-363-2; OA PLUS Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each, Herbal Dietary Supplement. Recall #. D-364-2; HEPASTAT Capsules, Liver Formula, 90 capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-365-2; NEUTRALIS Capsules, Immune System Formula, 30 capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-366-2; OSPORO Capsules, Skeletal Formula, 30 Capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-367-2; POENA Capsules, Muscle and Tissue Formula, 30 capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-368-2; ARTHRIN Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each, Herbal Dietary Supplement. Recall # D-369-2. CODE All codes. RECALLING FIRM/MANUFACTURER Botanic Lab, Brea, CA, by letter on May 24, 2002. Firm initiated recall is ongoing. REASON Products contain various amounts and combinations of undeclared prescription drug ingredients-Alprazolam, Indomethacin, Ethinyl Estradiol, and/or DES. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Quinaglute Dura-Tabs, Extended Release Tablets (quinidine gluconate, USP) 324 mg, 100, 250, and 500 count bottles, Rx. Recall # D-370-2. CODE Lot Numbers: W00238 Exp. 11/2004 W00239 Exp. 12/2004 W00240 Exp. 1/2005 W10001 Exp. 3/2005 W10028 Exp. 4/2005 W10029 Exp. 5/2005 W10111 Exp. 7/2005. RECALLING FIRM/MANUFACTURER Berlex Laboratories, Inc., Wayne, NJ, by letters on July 23, 2002. Firm initiated recall is ongoing. REASON Metal particles in tablets. VOLUME OF PRODUCT IN COMMERCE 2,603 bottles of 100's; 3,358 bottles of 250's; 15,286 bottles of 500's. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg, 1,000 count bottles, Rx only. NDC# 0046-0866-91. Recall # D-357-2. CODE Lot #15570, Exp. 08/08/02. RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by fax on July 8, 2002. Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failure to meet USP dissolution specifications by manufacturer (Wyeth). VOLUME OF PRODUCT IN COMMERCE 239 bottles. DISTRIBUTION OH, NJ, KY, AL, MO, ID, TX, VA, FL, and NC. _______________________ PRODUCT Premarin Tablets (conjugated estrogens tablets, USP), 1.25 mg, 100 tablet bottles, Rx only. NDC 0046-0866-81. Recall # D-358-2. CODE Lot #9000481D, Exp. 01/05. RECALLING FIRM/MANUFACTURER Recalling Firm: National Pharmpak Services, Inc., Zanesville, OH, by letter on June 19, 2002 Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failure to meet USP dissolution specifications by manufacturer (Wyeth). VOLUME OF PRODUCT IN COMMERCE 9,601 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Desyrel Tablets (Trazodone HCL), 100 mg, 100 count bottles, Rx only. NDC # 0025-0061-31. Recall # D-359-2. CODE Lot #011751, Exp. Nov 02, and Lot #012056, Exp. Aug 03. RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by fax on July 9, 2002. Manufacturer: Mead Johnson Pharmaceuticals, Evansville, IN. Firm initiated recall is ongoing. REASON Lack of uniformity of dosage-subpotent tablets (stability 18 month) by manufacturer-Mead Johnson Pharmaceuticals A Bristol Myers Squibb Co. VOLUME OF PRODUCT IN COMMERCE 646 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Glucagon Kit, Glucagon for Injection, USP TROUSSE DE GLUCAGON, 1 mg (1 unit)/vial (with 49 mg Lactose) (Product #M-8239, DIN 00015377). Recall # D-360-2. CODE Lots 4ND49M (exp. 12/1/02) and 4ND49N (exp. 3/1/03). RECALLING FIRM/MANUFACTURER Eli Lilly and Co., Indianapolis, IN, by letter on May 30, 2002. Firm initiated recall is ongoing. REASON Subpotent-out of specification result at 12 month time point for potency (the rat hepatocyte test). VOLUME OF PRODUCT IN COMMERCE 34,028 UNITS (Lot 4ND49M) and 24,835 UNITS (LOT 4ND49N). DISTRIBUTION Canada. _______________________ PRODUCT Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension, USP), 150 mg/ml, Single-Dose Vial, For intramuscular use only, one 1ml vial, Rx Only. NDC 0009-0746-30. Recall # D-361-2. CODE Lot 79HWX, Exp. Date 4/06. RECALLING FIRM/MANUFACTURER Pharmacia Corp., Kalamazoo, MI, by letter dated July 10, 2002. Firm initiated recall is ongoing. REASON May contain particles of inert polymeric material from a pumping hose. VOLUME OF PRODUCT IN COMMERCE 14,653 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Gentle Lubricant Eye Drops, Sterile, 1 FL. OZ. (30 mL) plastic Bottles. Recall # D-371-2. This OTC product was distributed under the following labels: - Sav-on Osco by Albertson’s(TM) Gentle Lubricant Eye Drops, Sterile, NDC 41163-951-30. - Equate(R) sterile gentle lubricant eye drops, 1 FL OZ (30 mL), NDC 54799-951-30. CODE Lot number 10309, expiration date 10/03 Equate brand: NDC # 54799-951-30, barcode # 15718 95130 Sav-on Osco brand: NDC# 411163-951-30, barcode # 41163 25390. RECALLING FIRM/MANUFACTURER Altaire Pharmaceuticals, Inc., Aquebogue, NY, by letter on July 16, 2002. FDA initiated recall is ongoing. REASON Subpotent (by manufacturer). VOLUME OF PRODUCT IN COMMERCE 11,312 bottles distributed. DISTRIBUTION OR, AZ, GA, MI, PA, AR, MS, TX and AL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1633-2. CODE Unit 1848869. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by telephone on August 14, 2001 and by fax dated September 10, 2001. Firm initiated recall is complete. REASON Blood product, which was manufactured in a manner that compromised the sterility of the collection system, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-1634-2; CODE Unit 7048066 - split unit; RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated December 7, 2001 and May 16, 2002. Firm initiated recall is complete. REASON Platelets, collected from a donor taking the medication Dipyridamole, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1636-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1637-2; c) Platelets, Recall # B-1638-2; d) Fresh Frozen Plasma, Recall # B-1639-2; e) Recovered Plasma, Recall # B-1640-2. CODE a) Units 13GX34966, 13FG62170, 13GM08425, 13FH28978, 13GC34272, 13FT73918, 13R68472, 13FH02638, 13M66285, 13FL15865, 13FL02563, 13FL09120, 13Y17218, 13G75554, 13H71289, 13J42253, 13H46724, 13FC78193, 13J99465, 13H38465, 13Y75922, 13J70168, and 13H85317; b) Units 13GC87026, 13GM42194, 13FC01158, 13X75264; c) Units 13GC87026, 13GM42194, 13FC01158, 13FH28978, 13X75264, 13FT73918, 13R68472, 13M66285, 13FL02563, 13Y17218, 13G75554, 13H71289, 13J42253, 13H46724, 13FC78193, 13J99465, 13H38465, 13J88020, 13Y75922, 13J70168, 13H85317; d) Units 13GX34966, 13FC01158, 13GM08425, 13R68472, 13FL02563; e) Units 13GM42194, 13FG62170, 13FH28978, 13GC34272, 13X75264, 13FT73918, 13FH02638, 13M66285, 13FL15865, 13Y42290, 13FL09120, 13Y17218, 13G75554, 13H71289, 13J42253, 13H46724, 13FC78193, 13J99465, 13H38465, 13J88020, 13Y75922, 13J70168, 13H85317. RECALLING FIRM/MANUFACTURER American Red Cross, Southeastern Region, Detroit, MI, by letters beginning on May 18, 2001. Firm initiated recall is complete. REASON Blood products, which tested non-reactive for anti-HIV-1/2, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2, were distributed. VOLUME OF PRODUCT IN COMMERCE 76 units. DISTRIBUTION MI, CA and FL. _______________________ PRODUCT Red Blood Cells, Leukocytes Removed, Recall # B-1641-2. CODE Unit FJ65609. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center (RIBC), Providence, RI, by telephone on March 1, 2001 and July 31, 2001. Firm initiated recall is complete. REASON Blood product, not quarantined after receiving post donation information related to a family member diagnosed with Creutzfeldt-Jakob Disease (CJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1643-2. b) Platelets, Recall # B-1644-2; c) Recovered Plasma, Recall # B-1645-2. CODE a) and b) Unit 13GM64690; c) Units 13GM64690, 13FH88809. RECALLING FIRM/MANUFACTURER American Red Cross, Southeastern Region, Detroit, MI, by letter dated December 13, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had lived in Western Europe for greater than 6 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MI and CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1647-2; b) Fresh Frozen Plasma, Recall # B-1648-2. CODE a) and b) Unit 01KX57413. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated December 7, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who tested negative for anti-HIV- 1/2, but previously tested repeatedly reactive for anti-HIV-1/2, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1650-2; b) Red Blood Cells Leukoyctes, Recall # B-1651-2; c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1652-2; d) Cryoprecipitate, Recall # B-1653-2; e) Fresh Frozen Plasma, Recall # B-1654-2; f) Platelets, Recall # B-1655-2; g) Recovered Plasma, Recall # B-1656-2. CODE a) Unit 10726-2811; b) Units 10724-3241, 10724-3242, 10724-8418, 10724-8433, 10725-1817, 10725-1819, 10725-1822, 10725-1824, 10725-1826, 10725-3842, 10725-3852, 10725-3857, 10725-3859, 10725-3866, 10725-5583, 10725-5669, 10725-5672, 10725-5673, 10725-5674, 10725-5677, 10725-5773, 10725-5776, 10725-6373, 10725-6384, 10725-7790, 10725-8045, 10725-9103, 10726-1334, 10726-1345, 10726-2813, 10726-2816, 10725-3851; c) Unit 1725-5589; d) Units 10725-3859, 10725-3866, 10725-5589, 10725-7790, 10726-1334; e) Units 10724-8418, 10725-1822, 10725-3851, 10725-3857, 10725-5583, 10725-5673, 10725-5773, 10725-5776, 10725-6373; f) Units 10726-2811, 10726-2813, 10726-2815; g) Units 10724-3241, 10724-3242, 10724-8433, 10725-1817, 10725-3842, 10725-3852, 10725-5674, 10725-8045, 10725-5589; RECALLING FIRM/MANUFACTURER Blood Systems, Inc., (AKA United Blood Services of Arizona), Scottsdale, AZ, by telephone on February 14, 2002 and by letter dated March 13, 2002. Firm initiated recall is complete. REASON Blood products, collected in a manner that compromises the sterility of the collection system, were distributed. VOLUME OF PRODUCT IN COMMERCE 59 units. DISTRIBUTION AZ and Germany. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1689-2; b) Cryoprecipitated AHF, Recall # B-1690-2; c) Platelets, Recall # B-1691-2; d) Fresh Frozen Plasma, Recall # B-1692-2. CODE a) Unit numbers 22FK79402 and 22GV60131; b) Unit number 22FK79402; c) Unit number 22GV60131; d) Unit number 22GV60131. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on May 29, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION NJ and PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1701-2. CODE Units 09V61425, 09V61426, 09V61430, 09V61432, 09V61433, 09V61437. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Midwest Region, Omaha, NE, by telephone on December 22, 2000 and by letters dated December 29, 2000. Firm initiated recall is complete. REASON Blood products, shipped at an unacceptable temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION NE. _______________________ PRODUCT Source Plasma, Recall # B-1703-2. CODE Units 10 80V364, 10 80U146, 10 80V933, 10 80Y301, 10 9D3090, 10 9D3833, 10 41H596, 10 9EE875, 10 9E1979, 10 9EJ330, 10 9FV366, 10 9GT957, 10 9HH836, 109HJ069, 10 9L1031, 10 9L1958, 10 9L3155, 10 9L4447, 10 9M4889, 10 9M5933, 10 9T2180, 10 9T3161, 10 9X0630, 10 93J729, 10 93K638, 10 93L423, 10 80U884, 10 80V643, 10 80X757, 10 9D0630, 10 9D3353, 10 9D4127, 10 41H877, 10 9EF179, 10 9E1372, 10 9FU738, 10 9FW173, 10 9GU300, 10 9HI049, 10 9L0784, 10 9L1711, 10 9L2806, 10 9L3877, 10 9M4531, 10 9M5561, 10 9Q2097, 10 9T2391, 10 9T3339, 10 9XP003, 10 93J925, 10 93K977, 10 93M366, 10 93M530, 10 930279, 10 CCDBHZ, 10 CCDDRL, 10 CCFLKB, 10 93N949, 10 CCCJVB, 10 CCDBWL, 10 CCDFHP, 10 80W621, 10 9Q3093, 10 80W937. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO, by fax on August 9, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of using hard drugs, were distributed. VOLUME OF PRODUCT IN COMMERCE 64 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1708-2; b) Cryo Poor Plasma, Recall # B-1709-2; c) Cryoprecipitated AHF, Recall # B-1710-2. CODE a); b) and c) Unit KS35991. RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by telephone on May 22, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor that subsequently provided disqualifying information, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA and OH. _______________________ PRODUCT Human Cornea Tissue, Recall # B-1734-2. CODE Tissue # 2002-06-3005 and # 2002-06-3006. RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone, letter and fax on June 24, 2002. Procuring Organization: Heartland Lions Eye Banks, Springfield, MO. Firm initiated recall is complete. REASON Human corneas, collected from a donor who subsequently tested positive for antibody to the Hepatitis B core antigen (anti-HBc) by another tissue procurement organization, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION KS and MD.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT a) Helixate FS, Antihemophilic Factor (Recombinant), 615 IU/vial, Recall # B-1493-2; b) Helixate FS, Antihemophilic Factor (Recombinant), 624 IU/vial, Recall # B-1494-2; c) Kogenate FS, Antihemophilic Factor (Recombinant), 655 IU/vial, Recall # B-1495-2; d) Kogenate FS, Antihemophilic Factor (Recombinant), 639 IU/vial, Recall # B-1496-2. e) Lypholized powder for injection. CODE a) Lot 372J001C; b) Lot 372J023A; c) Lot 372J009A; d) Lot 372J033C. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Biological Products, Berkley, CA, by letters dated September 15, 2000, September 13, 2001 and January 9, 2002. Manufacturer: Bayer Corporation, Pharmaceutical Division, Elkhart, IN. Firm initiated recall is complete. REASON Product did not meet the potency specification when store at room temperature. VOLUME OF PRODUCT IN COMMERCE a) 9,817 distributed; b) 11,160 distributed; c) 22, 208 distributed; d) 9,593 distributed. DISTRIBUTION PA and Canada. _______________________ PRODUCT Platelets, Recall # B-1635-2. CODE Unit 1784604. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated December 7, 2001 and May 16, 2002. Firm initiated recall is complete. REASON Platelets, collected from a donor taking the medication Dipyridamole, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1646-2. CODE Unit 16LM59332. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on May 6, 2002. Firm initiated recall is complete. REASON Red Blood Cells, that failed the red cell recovery ratio, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets, Recall # B-1702-2. CODE Units 09V61417, 09V61426, 09V61427, 09V61428, 09V61431, 09V61435, 09V61436, 09V61437, 09V61438, 09V61441 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Midwest Region, Omaha, NE, by telephone on December 22, 2000 and by letters dated December 29, 2000. Firm initiated recall is complete. REASON Blood products, shipped at an unacceptable temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION NE. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1704-2. b) Recovered Plasma, Recall # B-1705-2. CODE a) Units 02FH98883, 02FH98884, 02FH98885, 02FH98886, 02FH98887, 02FH98888, 02FH98889, 02FH98890, 02FH98891, 02FH98892, 02FH98893, 02FH98894, 02FH98895, 02FH98896, 02FH98897, 02FH98898, 02FH98899, 02FH98900, 02FH98901, 02FH98902, 02FH98903, 02FH98904, 02FH98905, 02FH98906, 02FH98907, 02FH98908, 02FH98909, 02FH98910, 02FH98911, 02FH98912, 02FH98913, 02FH98914, 02FH98915; b) Units 02FH98884, 02FH98885, 02FH98886, 02FH98887, 02FH98888, 02FH98889, 02FH98890, 02FH98891, 02FH98892, 02FH98893, 02FH98894, 02FH98895, 02FH98896, 02FH98897, 02FH98898, 02FH98899, 02FH98900, 02FH98901, 02FH98902, 02FH98903, 02FH98904, 02FH98905, 02FH98906, 02FH98907, 02FH98908, 02FH98909, 02FH98910, 02FH98911, 02FH98912, 02FH98913, 02FH98914, 02FH98915. RECALLING FIRM/MANUFACTURER American Red Cross, Central Plains Region, Wichita, KS, by telephone on August 24, 2001 and by letters dated August 28, 2001. Firm initiated recall is complete. REASON Blood products, exposed to unacceptable shipping temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE a) 33 units. b) 32 units. DISTRIBUTION KS. _______________________ PRODUCT Red Blood Cells, Recall # B-1706-2. CODE Unit KL05327. RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by telephone on February 12, 2002. Firm initiated recall is complete. REASON Blood product, labeled with incorrect or missing antibody information, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WV.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremeties. These images and/or spectra, when interpreted by a trained physician, yeild information that may assist in diagnosis. The coils are used to obtain optimal imaging. Recall # Z- 1147-2. CODE Release 6. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated October 26, 2001. Manufacturer: Philips Medical Systems, Nederland B.V. Netherlands. Firm initiated recall is complete. REASON Higher than expected current in the insulation of the coil cable. VOLUME OF PRODUCT IN COMMERCE 3. DISTRIBUTION FL and WA. END OF ENFORCEMENT REPORT FOR AUGUST 7, 2002####
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