April l1, 2001 01-14RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: a) Temple of Heaven Brand Chinese Herbs, Top Grade, Radix Aristolochiae, Net Wt. 16 oz. (1 lb.). Recall #F-334-1; b) Plum Flower Brand, Sulphur Free - Chlorine Free - Aluminum Phosphate Free, Ma Dou Ling, Aristolochia, MW# 5344, Net. Wt. 250g (8.83 oz.). Recall #F-335-1; c) Chinese Herb Frucutu Aristolochiae Net Wt. 16 oz. (1 lb.). Recall #F-336-1; d) Plum Flower, Fructus Aristolochiae, Herbal Extract Powder, Net Wt. 3.5 oz. (100g). Recall #F-337-1; e) Plum Flower Brand Single Herb Extract Full Spectrum 5:1 Herb Extract Powder, Ma Dou Ling, Aristolochia Debilis Fruit, MW# 5344C, Net Wt 3.5 oz. (100 g). Recall #F-338-1. CODE: All Codes. MANUFACTURER: a) Sam Luen Co., Hong Kong, b) Anguo MeiWei Medicinal Herbs, Anguo, China, c) Lam Hoi Trading Co., Hong Kong, d) Shanghai Institute of Herbal Products, Shanghai, China, e) Shanghai Institute of Herbal Products, Shanghai, China RECALLED BY: Mayway Corp., Oakland, CA, by letter and telephone on 12/14/00, and by press release on 12/18/00. FDA-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 48 bags/lb; 15 bottles/3.5 oz. REASON: The products contain aristolochic acid, a potent carcinogen and nephrotoxin. ________ PRODUCT: a) Lotus Herb Fang Ji (Stephania tetranda radix) Premium Herbal Product, 3.5 oz. plastic bottle. Recall # F-339-1; b) Lotus Herb Mu Tong (Clematis armandi) Premium Herbal Product, 3.5 oz. plastic bottle. Recall # F-340-1. CODE: a)SW12261, expiration date 12/2004; b)coded SL04461, expiration date 09/2004. MANUFACTURER: Lotus Herb Products, Sung-shan District, ROC. RECALLED BY: Lotus Herbs, Inc., La Puente, CA., by letter dated January 2, 2001 and nationwide press release on Jan. 4, 2001. FDA-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Fang Ji 48 bottles, Mu Tong 192 bottles. REASON: The products contain aristolochic acid, a potent carcinogen And nephrotoxin. ________ PRODUCT: a) Qualiherb brand Dianthus Formula, Ba Zheng San, item #20209. Recall #F-341-1; b) Qualiherb brand Stephania & Astragalus Combination, Fang Ji Huang Qi Tang, item # 20711. Recall #F-342-1; c) Qualiherb brand Clematidis Armandii Caulis, Chuan Mu Tong, item # 10424A. Recall #F-343-1; d) Qualiherb brand Clematidis Radix, Wei Ling Xian, item # 12401. Recall #F-344-1; e) Qualiherb brand Stephaniae Tetrandrae Radix, Han Fang Ji, item # 10731. Recall #F-345-1; f) Qualiherb brand Aristolochiae Fructus, Ma Dou Ling, item # 11052. Recall #F-346-1. CODE: All Codes. MANUFACTURE: Sheng Chang Pharmaceutocal Co., Ltd., Chung Ho City, Taipei, Taiwan. RECALLED BY: Sheng Chang Qualiherb, a Division of Finemost Corporation, Cerritos, CA., by letter on Jan. 2, 2001, and Press Release on January 4, 2001. FDA-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: Undetermined. REASON: The products contain aristolochic acid, a potent carcinogen and nephrotoxin.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: Cheese enchiladas. Recall #F-318-1. CODE: # 2103752, SYSCO Cheese Enchilada 1.625 oz./90 CT. MANUFACTURER: Fernando’s Food Corporation, Compton, CA. RECALLED BY: Manufacturer, by letter on November 6, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: 1,415 cases. REASON: The product was manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. ________ PRODUCT: Golden brand Dried Noodle. Recall #F-319-1. CODE: None. MANUFACTURER: Fujian Provincial Cereal, Oils, + Foodstuffs Import & Export Corp., Fuzhou, China. RECALLED BY: Strong America Limited, Brooklyn, NY., by letter on 5/5/00. Completed recall resulted from sample analysis and follow-up by the New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY, CT, FL, GA, OH, PA, VA, and Washington DC. QUANTITY: 61 cases (50 - 14 oz. packages per case). REASON: The product contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT: Chicken Salad Sandwich in 5 oz. and 7.4 oz plastic wrapped packages. Recall #F-347-1. CODES: All implicated lots. MANUFACTURER: REL’S Foods Inc., Oakland, CA. RECALLED BY: Manufacturer, by pager and telephone calls on 1/31/01. DISTRIBUTION: NV and CA. QUANTITY: 4,727 thin (5 oz.) and 4,963 thick (7.4 oz.) chicken salad sandwiches. REASON: The product contains undeclared sweetened condensed milk. ________ PRODUCT: Carroll Shelby’s Original Texas Brand Chili Kit, sales Units are 4 ounce kits (bags) packaged in 12 count,60 count, 96 count or 120 count per box. Recall #F-348-1. CODE: UPC codes with the following code dates: Count UPC Date Code 12 7239610000 2920, 2930, 2940, 2970, 2980, 3040, 3050, 3070, 3080, 3140, 3150, 3190, 3200, 3210, 3220, 3250, 3270, 3320, 3330, 3340, 3350 60 7239670250 2990, 3000 96 7239670230 3060, 3110, 3120, 3130, 3180, 3190, 3260, 3270 120 7239670240 3000, 3040, 3130, 3140. MANUFACTURER: Reily Foods Company, New Orleans, LA. RECALLED BY: Manufacturer, by letter on March 29, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 723,192 UNITS. REASON: The product was manufactured using an ingredient Which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. ________ PRODUCT: Meat free/veggie corn dogs: a) Morningstar Farms meat-free Corn Dogs, 10 oz., 15 oz., and 64 count. b) Loma Linda brand Meatless Corn Dogs, 10 oz and 10.5 oz, and Completely Meatless, 10 lbs. c) Natural Touch Veggie Corn Dogs, 10 oz. Recall #F-353-1; Mini meat free/veggie corn dogs: a) Morningstar Farms meat-free Mini Corn Dogs, 10 oz and 40 oz. Recall #F-354-1; Party pack containing meat-free/veggie corn dogs: a) Morningstar Farms Party Pack (Chick Nuggets, Mini Corn Dogs, and Buffalo Wings), 31 oz. Recall #F-355-1. CODE: All lots on the market at the time the recall was initiated. MANUFACTURER: Alpete Meats, Muncie, IN. RECALLED BY: Kellogg Company, Battle Creek, MI., by letter on March 14, 2001. Firm-initiated recall ongoing. DISTRIBUTION: United States, Canada, and Caribbean. QUANTITY: 441,206 cases. REASON: The products may have been manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Epifine Aceto Balsamic Vinegar 16.9 fl. Oz. Bottles. Recall #F-312-1. CODES: Best before 10-5-03. MANUFACTURER: Epifine BV, Netherlands. RECALLED BY: Tops Markets, Williamsville, NY., by e-mail on 3/2/01. Complete recall resulted from sample analysis and follow-up by the New York State Dept. of Agriculture and Markets. DISTRIBUTION: NY and OH. QUANTITY: 288 bottles. REASON: The product contains undeclared sulfites.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: Midazolam HCl Injection, 1 mg/ ml and 5 mg/ml; the product was filled in 3.5 ml vials, 10 vials per carton, in the following strengths and sizes: a) 1 mg/ml - 2 ml fill vial, NDC 60505-0711-1. Recall #D-156-1; b) 5 mg/ml - 1 ml fill vial, NDC 60505-0712-1. Recall #D-157-1. 2 ml fill vial, NDC 60505-0712-2 CODE: a) 1 mg/ml: 2 ml vials, lots 0C590, 0C630, 0C640, 0C960, 0C970, 0D670, 0D750 b) 5 mg/ml: 1 ml vials, lots 0C810, 0C820, 0C910 2 ml vials, lots 0C900, 0C980 Manufacturer: Novex Pharma, Ontario, Canad. RECALLED BY: Aptoex Corp., Vernon Hills, IL, by letters dated 3/6/01. Firm-initiated recall ongoing. DISTRIBUTION: California, Michigan, Washington, Hawaii and Oregon. QUANTITY: 64320 2 ml vials-1 mg., 3110 1 ml vials & 3890 2 ml vials-5mg. REASON: Lack of assurance of sterility - cracks in some vials. ________ PRODUCT: (Rx) Isoxsuprine HCI tablets, 20 mg, 1,000 count. Recall #D-162-1. CODES: Lot Nos. 00504, 00602, and 00603. MANUFACTURER: Integrity Pharmaceutical Corp., Fishers, Indiana. RECALLED BY: Manufacturer, by telephone on August 14, 2000, and by letter on August 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION: United States. QUANTITY: 11,818 bottles. REASON: Metal particles in tablets. ________ PRODUCT: Taxotere (docetaxel) for Injection Concentrate 20-mg., 20-mg. docetaxel in 0.5 ml polysorbate 80, 10 mg/ml after the initial dilution, RX, for IV infusion only, indicated for the treatment of breast cancer and non-small cell lung cancer, NDC #0075-8001-20, NDA #20-449. The product consists of two vials. One vial contains the Taxotere and has a green flip-top cap, and the other vial contains Diluent for Taxotere 20 mg., containing 13% (w/w) ethanol in water for injection, and has a clear flip-top cap. The two vials are packaged together in a labeled tray. The tray is contained within a labeled box. Recall #D-165-1. CODES: Lot #OP273 (Taxotere), OT446 (Diluent), Exp. 4/2002; Lot #OP273 (Taxotere), OT449 (Diluent), Exp. 4/2002. MANUFACTURER: Aventis Pharma, Ltd., England, UK. RECALLED BY: Aventis Pharmaceuticals, Inc., Kansas City, MO, via telephone on 3/23/01 and by fax on 3/27/01. Firm-initiated recall ongoing. DISTRIBUTION: AL, IL, TN, NC, MN, FL, OH, KY, MA, NJ, OR, CA, SC, and MI. QUANTITY: 28,774/2-vial units REASON: Mislabeling; Both the active ingredient vial and the diluent vial are labeled as DILUENTS.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: OTC) Acetaminophen Caplets, Extra Strength, 500 mg, 24,50,100, 120, 175, and 500 count. Recall #D-152-1. CODES: Lot Number 1281 (Bulk Lot Numbers W9071027R, W9071028R, W9081167R, W9081168R, W9091370R, W9101447R, W0020276R) Lot Numbers: 0010027, 0019523, 0044473, 0044390, 0044393, 0044641, 0044642, 0044643, 0044644, 0054814, 0055201, 0055202, 0055203, 0055204, 0055959, 0055960, 0067254, 0067255, 9082276, 9082277, 9082278, 9082280, 9082281, 9082282, 9082284, 9082285, 9082320, 9082321, 9082322, 9082323, 9093579, 9093579, 9094484, 9094485, 9094486, 9094487, 9094488, 9094490, 9094491, 9094492, 9094493, 9094494, 9094582, 9094583, 9094586, 9094588, 9094591, 9094592, 9094593, 9094705, 9105451, 9105857, 9106368, 9106369, 9106370, 9106371, 9106372, 9106375, 9106380, 9106385, 9106388, 9106391, 9106395, 9116914, 9117201, 9117217, 9117218, 9117223, 9117225, 9117227, 9117228, 9117230, 9117365, 9128851. MANUFACTURER: Leiner Health Products, Inc., Wilson, NC . RECALLED BY: Leiner Health Products, Inc., Carson, CA, by letter on January 15, 2001. Firm-initiated recall ongoing. DISTRIBUTION: AR, CT, FL, IN, MA, MN, NJ, NY, NC, OH, PA, TN. QUANTITY: 376,801 units were packaged and 362,953 units were distributed. REASON: MIS-LABELING; Labeling incorrectly declared an extended expiration date. ________ PRODUCT: a) MGP Multi-Vita Drops with Fluoride 0.25 mg., product code 8659, NDC 60432-659-50. Recalled #-158-1. b) MGP Multi-Vita Drops with Fluoride 0.5 mg., product code 8496, NDC 60432-496-50. Recall #D-159-1. CODES: Product Code 8659, lots 22647A, 22431A, 22657A, 22534A, 22534C, 22534E, 22884-A, 22998A, 23077A, 23184A, 23232A, 23351A; Product code 8496, lots 22308A, 22460A, 22602A, 22602C, 22769A, 23000A, 23000C, 23032A. MANUFACTURER: Morton GrovePharmaceuticals, Inc., Morton Grove, IL. RECALLED BY: Manufacturer, by letters dated 3/14/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 434378 – 0.25 mg. Fluoride bottles, 53323 – 0.5 mg. Fluoride bottles. REASON: Subpotency prior to expiration date; vitamin C (ascorbic acid.) ________ PRODUCT: (Rx)Fluocinolone Acetonide Solution, USP, 0.01%, 20 and 60 mL units. Recall #D-160-1. CODE: LOT NO. N133, Exp. Date 12/01. MANUFACTURER: Thames Pharmacal Co., Inc., Ronkonkoma, NY. RECALLED BY: Manufacturer, by letter on 3/22/01. Firm-initiated recall ongoing. DISTRIBUTION: KY, FL, GA, NY, IL, MI, LA, AL, MO, WI, CA, TX, PA, MN, OH, and Puerto Rico. QUANTITY: 7,007 units of the 20 mL bottles and 3,450 units of the 60 mL bottles. REASON: Subpotency (12th month stability). ________ PRODUCT: Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution, USP)3 GM/ML, 5 ML Bottles, NDC 0085-0899-05 Gentak Sterile Solution, DC 17478-283-0,PRIVATE LABEL for AKORN, INC., Buffalo Grove, Illinois. Recall #D-161-1. CODE: LOT NO. EXP. DATE 0-AMS-2 10/2003 9-AMS-2 3/2002 9-AMS-3 6/2002 9-AMS-4 12/2002 8-AMS-5 5/2002 8-AMS-7 8/2001 8-AMS-9 8/2001 8-AMS-12 12/2001 GENTAK LABEL 9-AMS-1 2/2002 8-AMS-3 2/2001 8-AMS-4 5/2001 8-AMS-5 5/2001 8-AMS-8 8/2001 8-AMS-10 11/2001 8-AMS-11 11/2001 MANUFACTURER: SCHERING Labortories, Kenilworth, NJ. RECALLED BY: Manufacturer, by letters on 3/8/01 and telephone on 2/16/01. FDA(Firm)-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Approximately 389,089 units. REASON: Chemical Contamination-Dicyclohexyl Phthalate (DCHP) Product Label adhesive migration. ________ PRODUCT: Inderide LA 160 mg/50 mg caps (Propranolol HCL 160 mg/Hydrochlorothiazdie 50 mg), NDC 0046-0459-81, bottles of 100 caps. 24 bottles of 100's per shipper. Recall #D-163-1. CODE: Lot no. 999041 exp. date 7/01. MANUFACTURER: Wyeth Pharmaceuticals Company, Guayama, PR. RECALLED BY: Manufacturer, by letters dated 2/28/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 5, 576 bottles of 100. REASON: Dissolution failure for Hydrochlorothiazide component. ________ PRODUCT: True Care Decongestant Nasal Spray, 1/2 fl. oz., Ozymetazoline Hydrochoride 0.05%, NDC 57394-608-06. Recall #D-164-1. CODE: Lot N416 MANUFACTURER: Thames Pharmaceutical Co. inc., Ronkonkoma, NY./ RECALLED BY: Apothecary Products, INC., South Burnsville, MN. DISTRIBUTION: Kansas City, MO. QUANTITY: About 920 mislabeled bottles. REASON: Mislabeling; Failure to declare warning against use if heart disease exists. ________ PRODUCT: Geneva Pharmaceuticals Amoxycillin 250 mg capsules. Recall #D-166-1; Amoxycillin 500 mg capsules. Recall #D-167-1. NDC #00781-2020-01 (250 mg 100's); NDC #00781-2020-05 (250 mg 500's); NDC #00781-2613-01 (500 mg 100's); NDC #00781-2613-05 (500 mg 500's). CODES: Lot Numbers and exp dates: 107283 05/02 107284 05/02 107285 05/02 107297 06/02 108375 09/02 108376 09/02 108377 09/02 108378 09/02 108379 09/02 108865 11/02 108866 11/02 108867 11/02 108868 10/02 109430 11/02. MANUFACTURER: Biochemie GmbH, Tyrol, Austria. RECALLED BY: GENEVA Pharmaceuticals, Broomfield, CO, by letter on March 13, 2001. Firm-initiated recall ongoing. DISTRIBUTION: CO, FL, NY, OK, VA. QUANTITY: 7,495,900/ 250mg capsules, 14,859,600/ 500mg capsules. REASON: Unapproved Drug: Drug distributed prior to approval of manufacturing changes. ________ PRODUCT: a) (?) Premarin® tablets (conjugated estrogens tablets), 0.625 mg, 100 & 1,000 count bottles. Recall #D-168-1; b)(?) Premarin® tablets (conjugated estrogens tablets), 2.5mg, 100 count bottles Recall #D-169-1. CODES: Strength Bottle Size NDC # Leiner Lot #Wyeth-Ayerst Lot # a) 0.625mg 100 count 0046-0867-81 8K01061 9980299 0.625mg 100 count 0046-0867-81 8H03878 9980299 0.625mg 100 count 0046-0867-81 9D00864 9990298 0.625mg 1000 count 0046-0867-91 9D00862 9990298 0.625mg 1000 count 0046-0867-91 8H02890 9980299 b) 2.5mg 100 count 0046-0865-81 9F01554 9990283 MANUFACTURER: Ayerst Laboratories Inc. A Wyeth-Ayerst Company, Philadelphia, PA RECALLED BY: Manufacturer, by letter and fax on 12/8/00. Firm-initiated recall ongoing. DISTRIBUTION: NY, CA, IL. QUANTITY: Strength Bottle Size Wyeth-Ayerst Lot # Leiner Lot # #of Bottles Produced 0.625mg 100 count 9980299 8K01061 & 8H03878 5916 0.625mg 100 count 9990298 9D00864 & 9D00862 27,069 0.625mg 1000 count 9980299 8H02890 1800 2.5mg 100 count 9990283 9F01554 4200 REASON: Dissolution failure by manufacturer (AYERST LABORATORIES). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ________ PRODUCT: Source Plasma. Recall #B-744-1. CODES: Units: 03830673, 03836033, 03902929, 03908778, 01922745, 01926323, and 01930382. MANUFACTURER: Manufacturer: North American Biologicals, Inc, Evansville, IN. RECALLED BY: North American Biologicals, Inc. Boca Raton, FL., by letter dated August 25, 1998. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: 7 units. REASON: Blood products collected from an unsuitable donor, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-837-1; b) Platelets. Recall #B-838-1; c) Platelets, Pheresis. Recall #B-839-1; d) Platelets, Pheresis, Leukocytes Reduced. Recall #B-840-1; e) Fresh Frozen Plasma. Recall #B-841-1. f) Recovered Plasma. Recall #B-842-1. CODES: a) Units 4113781, 4112134, 7536078, 4060243, 6607287, 4411558, 6224868, 7856385, 5811383, 6081841, 4308070, 9039442, 9038546, 9037896, 3421338, 9035511, 6077241, 6074880, 2431860, 5911463, 5509312, 5507582, 5505575, 2339695, 8600907, 2328892, 7908986, 9038759, 9037668, 8207377, 8203706, 3424314, 3423091, 3421928, 1495592, 1493378, 9810499, 1494915, 5908327, 5905124, 2341546, 3582570, 3579237, 7049007, 7047948, 7047101, 7045812, 7045111, 6081598, 4804721, 2211685, 6611466, 2163535, 2160026, 7779943, 2153592, 7914452, 5513670, 5508850, 5507005, 4410410, 5512659, 7920794, 8168893, 7859589, 5809351, 4413369, 8059853, 7920203, 8056074, 8054920, 8053875, 4061078, 4059557, 6607269, 4057025, 5806024, 4321543, 3421722, 8601438; b) Units 7536078, 4411558, 5811383, 4308070, 6074880, 2431860, 5911463, 9038759, 1495592, 9810499, 1494915, 5908327, 5905124, 2341546, 3579237, 6081598, 6611466, 2163535, 7914452, 4410410, 8168893, 7859589, 5809351, 4413369, 7920203, 8056074, 4061078; c) Units 402888, 670334 (2 units), 6703304, 9408300; d) Units 3711616 (2 units), 3710644; e) Units 4411558, 6224868, 5811383, 2431860, 9038759, 9810499, 3579237, 6081598, 2163535, 7779943, 7914452, 4410410, 7920794, 5809351, 7920203, 4321543; f) Units 4113781, 4112134, 7536078, 4307537, 4062323, 4060243, 6607287, 7856385, 6081841, 4308070, 5504693, 2168853, 2423781, 9039442, 9038546, 9037896, 3421338, 9035511, 6077241, 6074880, 5911463, 5509312, 5507582, 5505575, 2339695, 8600907, 2328892, 7908986, 9037668, 8207377, 8203706, 3424314, 3423091, 3421928, 1495592, 1493378, 1494915, 5908327, 5905124, 3582570, 7049007, 7047948. 7047101, 7045812, 7045111, 4804721, 2211685, 6611466, 2160026, 2153592, 5508850, 5507005, 5505678, 5512659, 8168893, 7859589, 4413369, 8059853, 8056074, 8054920, 8053875, 4061078, 4059557, 6607269, 4057025, 5806024, 3421722, 8601438. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone and facsimile, between October 10, 2000 and November 3, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois, Pennsylvania, California and Switzerland. QUANTITY: 199 units. REASON: Blood products, collected from donors who had been deferred at another donor center, were distributed. ________ PRODUCT: Platelets Pheresis, Leukoreduced. Recall #B-851-1. CODES: Unit 22403-1530 MANUFACTURER: United Blood Services, Henderson, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated January 8, 1999. Firm-initiated recall complete. DISTRIBUTION: Nevada. QUANTITY: One unit. REASON: A Plateletpheresis product, with an elevated platelet count, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-852-1. CODES: Units 24GE11030, 24GE11042. MANUFACTURER: American Red Cross Blood Services, River Valley Region, Evansville, IN. RECALLED BY: American Red Cross Blood Services, River Valley Region, Louisville, KY., by telephone on December 5th and 6th, 2000, and by letters dated December 8, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana QUANTITY: Two units. REASON: Blood products, inappropriately prepared by combining the components into one platelet storage bag instead of two, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-857-1. CODES: Unit 01GT05738. MANUFACTURER: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY. RECALLED BY: Manufacturer, by Questionable Plasma Inquiry on August 17, 2000. Firm-initiated recall complete. DISTRIBUTION: Switzerland. QUANTITY: One unit. REASON: Blood product, collected from a donor with a history of having tested positive for Hepatitis B, was distributed. ________ PRODUCT: Platelets. Recall #B-882-1. CODES: Unit 33GJ21623. MANUFACTURER: American Red Cross, Connecticut Region, Farmington, CT. RECALLED BY: Manufacturer, by telephone on November 13, 2000, and followed up with a letter dated November 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Connecticut QUANTITY: One unit. REASON: Blood product, that was not quarantined after receiving information concerning post donation illness, was distributed. ________ PRODUCT: Red Blood Cells, Deglycerolized. Recall #B-883-1. CODES: Units 42FN09452, 42N13986, 42FZ91221, 42FZ91228, 42K13246, 42FX87880 MANUFACTURER: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH. RECALLED BY: Manufacturer, by letters dated November 9, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Six units. REASON: Blood products, deglycerolized with an expired reagent, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-884-1; b) Fresh Frozen Plasma. Recall #B-885-1; c) Recovered Plasma. Recall #B-886-1. CODES: a) Units 01LV25923, 01LV19564; b) Unit 01LV25923; c) Unit 01LV19564. MANUFACTURER: American Red Cross Blood Services, New York- Penn Region, Buffalo, New York. RECALLED BY: American Red Cross Blood Services, West Henrietta, NY, by letters dated February 1, 2000. Firm-initiated recall complete. DISTRIBUTION: New York and California. QUANTITY: Four units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: Carticel (Autologous Cultured Chondrocytes). Recall #B-907-1. CODES: Lot CC00284-21. MANUFACTURER: Genzyme BioSurgery, A Division of Genzyme Corporation, Cambridge, MA. RECALLED BY: Manufacturer, by telephone on January 11, 2001, and by letters dated January 11, 2001 and February 14, 2001. Firm-initiated recall complete. DISTRIBUTION: Maine. QUANTITY: One unit. REASON: Tissue repair product, contaminated with Sphingomanos species, was distributed. ________ PRODUCT: Red Blood Cells Leukocytes Removed. Recall #B-926-1. CODES: Units 1125395, 1119883, 1114997. MANUFACTURER: Community Blood Center, Datyton, OH. RECALLED BY: Manufacturer, by letters dated October 31, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio QUANTITY: Three units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-976-1; Red Blood Cells, Leukocytes Reduced. Recall #B-977-1. CODES: a) units 28GG50111, 28GG50113, 28GG50114, and 28GG50117; b) units 28GL26584 and 28LX05840. MANUFACTURER: American Red Cross Blood Services, Savannah, GA. RECALLED BY: The American National Red Cross, Southern Region, Atlanta, GA., by telephone on March 29, 1999, or by letter dated March 26, 1999. Firm- initiated recall complete. DISTRIBUTION: South Carolina, Georgia, and California. QUANTITY: Six units. REASON: Blood products, corresponding to units of Platelets which were pooled and possibly contaminated with Group C Beta Streptococcus sp., were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-979-1; b) Recovered Plasma. Recall #B-980-1. CODES: a)and b) unit number M08-24904. MANUFACTURER: Community Blood Council of New Jersey, Trenton, NJ. RECALLED BY: Manufacturer, by letters dated September 17, 1999, and September 24, 1999. Firm-initiated recall complete. DISTRIBUTION: New Jersey and Pennsylvania. QUANTITY: Two units. REASON: Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-981-1. CODES: Unit number W16-13467. MANUFACTURER: Community Blood Council of New Jersey, Trenton, NJ. RECALLED BY: Manufacturer, by letters dated September 17, 1999, and September 24, 1999. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: One unit. REASON: Blood product, that tested negative for antibody to hepatitis C virus (anti-HCV), but was collected from a donor that previously tested repeatedly reactive for anti-HCV, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-984-1. CODES: Unit number 12-441-7008. MANUFACTURER: United Blood Services, Albuquerque, NM. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on January 17, 2000. Firm-initiated recall complete. DISTRIBUTION: New Mexico. QUANTITY: One unit. REASON: Blood product, that tested reactive for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), was distributed. ________ PRODUCT: Source Plasma. Recall #B-985-1. CODES: unit number LO075462. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Lorain, OH. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ., by letter dated April 13, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, was distributed. ________ PRODUCT: Red Blood Cells Irradiated. Recall #B-986-1; Platelets. Recall #B-987-1; Fresh Frozen Plasma. Recall #B-988-1. CODES: a), b) and c) unit number C00-87281. MANUFACTURER: Community Blood Council of New Jersey, Trenton, NJ. RECALLED BY: Manufacturer, by letter dated March 21, 1999. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: Three units. REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: a) Red Blood Cells. Recall #B-843-1; b) Red Blood Cells, Washed. Recall #B-844-1; c) Platelets. Recall #B-845-1; d) Platelets, Pheresis, Irradiated. Recall #B-846-1; e) Platelets, Pheresis, Leukocytes Reduced and Platelets, Pheresis, Leukocyte Reduced, Irradiated. Recall #B-847-1; f) Fresh Frozen Plasma. Recall #B-848-1; g) Red Blood Cells For Use in Manufacturing Non-injectable Products Recall #B-849-1; h) Recovered Plasma. Recall #B-850-1. CODES: a) Units 6089495, 6087913, 6086321, 6085057, 6083615, 6082163, 6080803, 6078778, 6077345, 8049159, 8059353, 8057611, 8056789, 8055463, 5605087, 5604767, 5604324, 5603977, 5602795, 9036263, 2431613, 3423301, 7922283, 2168120, 2160260, 6113510, 7499200, 7049236; b) Unit 4062323; c) Units 6089495, 6083615, 6080803, 6078778, 7922283, 2160260; d) Unit 9408573; e) Units 3711721, 3711490, 3711260, 3711003 (2 units), 3710711, 3710500 (2 units), 3710375 (2 units), 3709893 (2 units), 3709701, 3711721, 3711490, 3711260, 3710711, 3709701; f) Units 6087913, 6113510; g) Unit 5603379; h) Units 6089495, 6086321, 6085057, 6083615, 6082163, 6080803, 6078778, 6077345, 8049159, 8059353, 8057611, 8056789, 8055463, 5605087, 5604767, 5604324, 5603977, 5603379, 5602795, 9036263, 2431613, 3423301, 7922283, 2168120, 2160260, 7499200. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone and facsimile, between October 10, 2000 and November 3, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois, Pennsylvania, California and Switzerland. QUANTITY: 83 units. REASON: Blood products, collected from donors who had been deferred at another donor center, were distributed. ________ PRODUCT: Platelets Pheresis, Leukoreduced. Recall #B-853-1. CODES: Units 041GP46079, 041GP46080, 041GP46081, 041GP46082, 041GP46083. MANUFACTURER: American Red Cross Blood Services, Alabama Region, Birmingham, AL RECALLED BY: Manufacturer, by letter dated June 16, 1999. Firm-initiated recall complete. DISTRIBUTION: Alabama. QUANTITY: Five units. REASON: Plateletpheresis products were distributed without platelet counts being performed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced, Irradiated. Recall #B-892-1. CODE: Unit 22416-9986 MANUFACTURER: United Blood Services, Las Vegas, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on November 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Nevada. QUANTITY: One unit. REASON: Red Blood Cells, Leukoreduced, that lacked assurance of proper storage temperatures due to inaccurate documentation, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-893-1. CODE: Unit 22417-0326 MANUFACTURER: United Blood Service, Las Vegas, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on August 16, 2000. Firm-initiated recall complete. DISTRIBUTION: Nevada. QUANTITY: One unit. REASON: Red Blood Cells, Leukoreduced, that lacked assurance of proper storage temperatures due to inaccurate documentation, was distributed. ________ PRODUCT: Recovered Plasma. Recall #B-978-1. CODE: units 28GG50111, 28GG50113, 28GG50114, 28GG50117, 28GL26584 and 28LX05840 MANUFACTURER: American Red Cross Blood Services, Savannah, GA. RECALLED BY: The American National Red Cross, Southern Region, Atlanta, GA., by telephone on March 29, 1999, or by letter dated March 26, 1999. Firm-initiated recall complete. DISTRIBUTION: South Carolina, Georgia, and California. QUANTITY: Six units. REASON: Blood products, corresponding to units of Platelets which were pooled and possibly contaminated with Group C Beta Streptococcus sp., were distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-982-1; b)Recovered Plasma. Recall #B-983-1. CODE: a) unit number H04-42455; b) unit number H04-42455. MANUFACTURER: Community Blood Council of New Jersey, Trenton, NJ. RECALLED BY: B-983-1 Recovered Plasma Manufacturer, by letters dated September 17, 1999, and September 24, 1999. Firm-initiated recall complete. DISTRIBUTION: New Jersey and Pennsylvania. QUANTITY: Two units. REASON: Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. _______ PRODUCT: Platelets, Pheresis - Leukocytes Reduced. Irradiated. Recall #B-990-1. CODE: unit 19236-2697. MANUFACTURER: United Blood Services, Reno, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ by telephone and letter on September 14, 1998. Firm-initiated recall complete. DISTRIBUTION: Nevada QUANTITY: One unit. REASON: Blood product, which was collected from a donor with an elevated body temperature, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-991-1. CODE: unit 38E83693. MANUFACTURER: American Red Cross Blood Services, Fort Wayne, IN. RECALLED BY: Manufacturer, by telephone on September 25, 1998. Firm-initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: One unit. REASON: Blood product, in which the corresponding platelets were contaminated with gram-positive branching rods, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced Irradiated. Recall #B-992-1. CODE: (14 units), unit numbers 0305912A, 1209686A, 1209686B, 1209686C, 1209686D, 1210009A, 1210009C, 0324057A1, 0324057A2, 4455444A, 1216962A, 1216962B, 1216962C, and 1216962D. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by letter dated December 11, 2000. Firm-initiated recall complete. DISTRIBUTION: Washington. QUANTITY: 14 units. REASON: Blood products, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-994-1. CODE: (11 units), unit numbers 0289817, 0291869, 1266993, 1267617, 2165828, 2165829, 2165846, 2165848, 3150517, 3150543, and 4114674. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO RECALLED BY: Manufacturer, by telephone on May 17 and 18, 1999. Firm-initiated recall complete. DISTRIBUTION: Missouri, Kansas, and Ohio. QUANTITY: 11 units. REASON: Blood products, stored at an incorrect temperature, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-995-1. CODE: unit numbers 6155355 and 6160935. MANUFACTURER: Community Blood Center of Greater Kansas City, Springfield, MO. RECALLED BY: Community Blood Center of Greater Kansas City, Kansas City, MO, by letters dated May 19, 1999, and May 24, 1999. Firm-initiated recall complete. DISTRIBUTION: Florida, and New Jersey. QUANTITY: Two units. REASON: Blood products, stored at an incorrect temperature, were distributed. ________ PRODUCT: Red Blood Cells. Recall # B-996-1. CODE: (10 units), unit numbers 10627-8935, 10629-0533, 10629-0024, 10629-3765, 30176-9598, 10629-5514, 10629-5547, 10629-0081, 10629-7232, and 10629-4182. MANUFACTURER: Blood Systems, Inc., Scottsdale, AZ. RECALLED BY: Manufacturer, by telephone on August 28, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: 10 units. REASON: Blood products, stored in an unmonitored refrigerator, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Ancure® Endograft® System. Recall #Z-346-1. CODE: Ancure Tube System Device Part Number: 13464. MANUFACTURER: Guidant Corporation/Endovascular Solutions , Menlo Park, CA. RECALLED BY: Manufacturer, via letter on March 9, 2001. Firm-initiated recall complete. DISTRIBUTION: CA. QUANTITY: 1 unit. REASON: Device component did not get ultrasonically washed. ________ PRODUCT: Femoral Hip Stems. Recall #Z-347-1. CODES: A)Lat. Answer Cemented Femoral 9 x 125 mm Lateralized Stem. Part 162501, lots 314750, 385750, 462760 and 538800. B)Lat. Answer Cemented Femoral 11.0 x 135 mm Lateralized Stem. Part 162502, lots 013820, 087010, 138970, 138980, 156390, 207720, 241120, 252630, 264810, 302780, 347780, 462770, 538810, 587870, 623710 and 666370. C)CB Answer Cemented Femoral 9.0 x 125 mm Stem. Part CP155895, lots 314520, 314530, 403400 and 462380. D)Mallory/Head Cemented Femoral Interlok /minus 5 mm neck, 5 mm x 7 mm. Part 105606, lots 029110, 155570, 338210 and 474040. E)Mallory/Head Cemented Femoral Interlok/with Collar 7.0 x 140 mm Stem. Part 105607, lots 113800, 113810, 137940, 137950, 155580, 170500, 183130, 183140, 194670, 207420, 229400, 264510, 013510, 099850, 289400, 289410, 302350, 435370, 487870, 487880, 500930, 511980, 511990, 523800, 523810, 538270, 549180, and 549190. F)Mallory/Head Collared Femoral 7.0 x 140 mm Stem. Part RD116807, lot 207230. G)Mallory/Head C Femoral Reduced 5P/7D x 105 mm minus 5 mm neck. Part 154682, lot 264440. H)Modified Mallory/Head C Femoral 5 mm x 7 mm x 115 mm stem minus 5 mm neck. Part CP154683, lot 326020. MANUFACTURER: Biomet Orthopedics, Inc., Warsaw, IN. RECALLED BY: Manufacturer, by facsimile letter on January 18, 2001. Firm-initiated recall ongoing. DISTRIBUTION: United States, Canada, France and Korea. QUANTITY: 159. REASON: The cobalt-chrome alloy may have a streak of pure cobalt. ________ PRODUCT: Boston Scientific/Microvasive Flexima Soft (Flexible) Tip Ureteral Catheter: Recall #Z-0348-1 to Z-0352-1. Catalog Number Description 400-215 4 French x 70 cm 400-216 5 French x 70 cm 400-217 6 French x 70 cm 400-218 7 French x 70 cm 400-219 8 French x 70 cm CODE: All Lots. MANUFACTURER: Boston Scientific Corp., Spencer, IN. RECALLED BY: Boston Scientific Corp., Natick, MA., by letter on 11/30/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide , VA Medical Centers in NC, FL, AR, and Madigan Army Medical, WA. Foreign: Singapore, Canada, France. QUANTITY: 859 boxes (all sizes) = Boxes of 20. REASON: Radiopaque flexible tip may detach from the Ureteral Catheter. ________ PRODUCT: BVS 42 French Arterial Cannula provided in the BVS Pump Set or as an individual cannula. Recall #Z-0353-1. CODES: Recall Lots Numbers: 00DPM3670 00DPM3770 00EPM0800 00EPM0810 00EPM1200 00EPM1360 00EPM1370 00EPM2100 00EPM2230 00EPM3430 00EPM3780 00EPM4550 00FPM2830 00FPM3010 00GPM2940 00GPM3260 00GPM3270 00HPM0070 00HPM3130 MANUFACTURER: Medtronic Cardiac Surgical Products, Rancho Dominguez, CA. RECALLED BY: Abiomed, Inc., Danvers, MA., by fax letter on 11/16/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, Canada, Spain, Japan, Australia, Sweden, Netherlands. QUANTITY: 220. REASON: Cannula may delaminate at the proximal connector end and not connect to Blood Pump. ________ PRODUCT: Pleur-Evac, Model A-6002. Recall #Z-0354-1. CODES: Lot Number:412335. MANUFACTURER: Genzyme Surgical Products Corp., Fall River, MA. RECALLED BY: Manufacturer, by telephone on October 25 and 26, 2000 and by letter on October 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION: CA, MS, FL, MA. MD, NC. and Canada. QUANTITY: 444Units. REASON: Breach in chamber wall may compromise water seal of chest drain. ________ PRODUCT: MultiDiagnost 3 Image Intensified Fluroscopic X-Ray System. Recall #Z-0355-1; MultiDiagnost 4 Image Intensified Fluroscopic X-Ray System. Recall #Z-0356-1. CODE: All systems installed prior to March 2000. MANUFACTURER: Philips Medical Systems, Best, Netherland. RECALLED BY: Philips Medical Systems North America, Inc., Shelton, CT., by notice to Service Representatives on October 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 53. REASON: Ankle clamp may detach from footplate and cause X-Ray table to tilt and tip. ________ PRODUCT: B-K Medical Laproscopic transducers, TYPES: 8566, 8566-S and 8666. Recall #Z-0357-1 to Z-0359-1. CODES: B-K Laproscopic transducers as follows: TYPE: S/N:8566 18167668566-S 1816755,1816756,1816758,1816759,1817050-1817059 1817061,1817064,1817066- 1817072, 1817074-1817076, 1821843 1817052,1817053, 8666 1817608-1817613, 1817616, 1817619-18177621 MANUFACTURER: B-K Medical A/S, Gentofte, Denmark. RECALLED BY: B-K Medical Systems, Inc., Wilmington, MA., by letter on October 9,2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 25. REASON: Defect at tip of laproscopic probe may effect disinfection and safety. ________ PRODUCT: Apligraf (Graftskin). Recall #Z-0360-1. CODE: Manufacturing Lot: GS0008.15.03 Unit Numbers: 1,3,4,5,10,11,13,14,15,17,19,20,22,24,25,28, 31,32, 33,35, 36,38,39,40, 41, 42,43,44,45,46,47,49,50,51,54,55,56,57,58,60, 62,63, 64,65,71,and 114. MANUFACTURER: Organogenesis, Inc., Canton, MA. RECALLED BY: Manufacturer, by telephone on September 11, 2000, and fax on September 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 46. REASON: Product Contamination-Staphyloccoccus cohnii. ________ PRODUCT: Ritter and Midmark brand Medical Examination Lights, ceiling mounted, AC-Powered, Models: 354 and 355. Recall #Z-0361-1. CODE: All Serial Numbers built between 1/4/2000 and 6/20/2000. MANUFACTURER: MIidmark Corp., Versailles, OH. RECALLED BY: Manufacturer, by letters on January 19, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Australia, Philippines, Netherlands, and France. QUANTITY: 446 units. REASON: The light arm assembly may fall from the ceiling, due to a manufacturing defect.RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II
________ PRODUCT: Custom Mixed Poultry Feed, bagged and sold as bulk, unlabeled poultry feed. Recall #V-014-1. CODE: The bags are uncoded. MANUFACTURER: Western Reserve Farm Coop., Middlefield, Ohio. RECALLED BY: Manufacturer, by telephone on February 28, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Approximately 820 pounds. REASON: The animal feed contains product derived from mammalian tissues and must bear the statement “Do not feed to cattle or other ruminants” on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. ________ PRODUCT: Custom Mixed Poultry Feed, packaged in unlabeled 100 pound bags and sold in bulk. Recall #V-015-1. CODE: The bags are uncoded. MANUFACTURER: Medina Landmark, Inc., Medina, Ohio. RECALLED BY: Manufacturer, by telephone on March 5, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Approximately 900 pounds of feed (9/100 pound bags). REASON: The animal feed contains product derived from mammalian tissues and must bear the statement “Do not feed to cattle or other ruminants” on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label.
END OF ENFORCEMENT REPORT FOR APRIL 11, 2001.
Office of Public Affairs
Hypertext uploaded by tg 2001-APR-11.