June 20, 2001 01-24RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: Viva brand Fresh Cantaloupe. Recall # F-416-1. CODE: All product shipped March 1, 2001 to May 22, 2001. MANUFACTURER: SPR de R.I. Los Arroyos, Empalme, Mexico and SPR Legumbrera de San Luis, Hermosillo. RECALLED BY: Shipley Sales Service, Nogales, AZ (distributor), by telephone and letter beginning on May 25, 2001. FDA initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Undetermined. REASON: The product was associated with an outbreak of Salmonella poona. ________ PRODUCT: STR brand Dried Sweet Potato packed in flexible plastic bags, net wt. 7 oz. Product of China. Recall # F-299-1. CODE: None MANUFACTURER: Xiamen Da Chang Hua Imp. & Exp. Co., Fujian, China Foreign supplier & possible manufacturer. RECALLED BY: Strong America Limited, Brooklyn, NY, by Press Release on July 3, 2000, and by letter dated October 2, 2000. Completed recall resulted sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY, MA, TN , NC, FL,IL and GA. QUANTITY: 151 cases (100 - 7 oz. packages per case) were distributed. REASON: The product contained undeclared sulfites. ________ PRODUCT: Nantucket Brownies-Chocolate Fudge Brownie, Net Weight 3 oz UPC 0-95155-06001-6. Recall # F-428-1. CODE: All product [as no lot code or use by date is on label]. MANUFACTURER: Boston Cookies,Somerville, MA. RECALLED BY: Manufacturer, by telephone, fax, and press release March 23, 2001. Firm initiated recall is complete. DISTRIBUTION: ME, NH, MA, RI, CT, NY, NJ, PA, DC, MD. QUANTITY: 26 cases (12x3 oz). REASON: The product contained undeclared walnuts.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: Sea Stix & Shrimp with Mayo, a seafood salad, ready-to-eat product, packaged in 5 LB containers. The product is labeled under the Euro Navillus brand name. Recall # F-418-1. CODE: BEST BEFORE: 4/26/01. MANUFACTURER: Herold's Salads, Inc., Cleveland, OH. RECALLED BY: Manufacturer, by telephone on 4/25/2001. Firm initiated recall is complete. DISTRIBUTION: OH. QUANTITY: 10 lbs. REASON: The product contains undeclared FD&C Yellow No. 6 and FD&C Red No. 40. ________ PRODUCT: a) Aprilís Potato Salad. Recall # F-419-1; b) American Potato Salad. Recall # F-420-1; c) Macaroni Salad. Recall # F-421-1; d) Mediterranean Salad. Recall # F-422-1; e) Spinach Dip. Recall # F-423-1; f) Artichoke Dip. Recall # F-424-1; g) Pea Salad. Recall # F-425-1. Products are in 5 lb. Poly bags. CODE: No code. MANUFACTURER: Dreamland, Inc., Shoreline, WA. RECALLED BY: Manufacturer, by telephone and visit beginningon 12/1/01. Firm initiated recall is complete. DISTRIBUTION: WA. QUANTITY: 629 - 5 lbs. Units. REASON: a) - d) The products contain undeclared FD&C Yellow No. 5. e) The productís label does not declare the ingredients of mayonnaise and sour cream. f) The productís label does not declare the ingredients of mayonnaise and parmesan cheese. g) The productís label does not declare the ingredients of mayonnaise. _______ PRODUCT: TRAILBLAZER MIX, packed in 8 oz plastic bags, packaged under the I.M. Good label. Recall # F-429-1. CODE: The product is uncoded. The recall affects all "Trailblazer Mix" in 8 oz. bags distributed from 1/3/2000 through 4/11/2001. MANUFACTURER: Tropical Nut & Fruit, Inc.,Columbus, OH. RECALLED BY: I. M. Good, Inc., Canton, OH, by letter on 4/26/2001. Ongoing recall resulted form followup by the New York State Department of Agriculture and Markets. DISTRIBUTION: AR, CT, DE, FL, GA, IL, IN, KS, ME, MD, MA, MI, MS, MT, NE, NH, NJ, NM, NY, NC, OH, PA, SD, TN, TX, VT, VA, WA, WV, AND WI. QUANTITY: 11,784 bags. REASON: The product contains undeclared FD&C Yellow No. 5 Lake, FD&C Yellow No. 6, FD&C yellow No. 6 Lake, FD&C Red No. 40, FD& C Red No. 40 Lake, Fd&C Blue No. 1 and FD&C Blue No. 1 Lake. ________ PRODUCT: a) Mieszko brand Duet Galaretka w Czekoladzie (chocolate candy with jelly and marshmallow filling) in bags with net wt. 220 g/ 7.74 oz. Recall # F-432-1. b) Mieszko brand Trio Galaretka w Czekoladzie (chocolate candy with jelly filling) in bags with net weight 200 g/7.04 oz. Recall # F-433-1. CODE: All codes on the market at the time the recall was initiated. MANUFACTURER: Z.P.C. Mieszko S.A. Raciborz, Poland. RECALLED BY: Square Enterprises Corporation, Passaic, NJ. DISTRIBUTION: NJ, NY, CT, and PA. QUANTITY: Duet 220gm -- 550 cases; Trio 220gm -- 550 cases (15 bags/case). REASON: The products contained the unapproved color additives Ponceau 4R and quinoline yellow. ________ PRODUCT: Hair & Body Shampoo, packed in 800 ml bags (inside a box), for use in the ìBag- In-Boxî dispensers, 12 per case. Recall # F-430-1. CODE: The following batch codes are recalled [all batches]: C032071, C031281, C060881, C073181, CC111781, C071291, C192191, C060101, and C091501. MANUFACTURER: Steiner Company, Inc., Holland, OH. RECALLED BY: Manufacturer, by facsimile 4/2/2001. Firm initiated recall is complete. DISTRIBUTION: IL. QUANTITY: 1,313 cases. REASON: The product contains the unapproved color additives C.I. Acid Blue #1, C.I. Acid Green #25, and C.I. Acid Yellow # 23.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Pathrop brand preserves: a) Raspberry Sugar Free preserve in glass jars. Recall # F-403-1. b) Cranberry Sugar Free Preserve in glass jars. Recall # F-404-1. c) Mountaine Cranberry Sugar free preserve in glass jars. Recall # F-405-1. CODES: a) Raspberry: UPC 601622 000698 b) Cranberry: UPC 601622 000674 c) Mountaine Cranberry: UPC 601622 000674 MANUFACTURER: Ratibor, Moscow, Russia. RECALLED BY: B&B International Connections, Brooklyn, NY. DISTRIBUTION: NY, and MA. QUANTITY: 86 cases. REASON: Products were misbranded because they were labeled as sugar free when they contained sugars. Additionally the Cranberry and Mountain cranberry flavors contained undeclared sodium benzoate. ________ PRODUCT: a) Nonpareil Pattie, 2 oz. pattie in cellophane. Recall # F-406-1. b) Season Non-Pareil, 8 oz. cellophane bag. Recall # F-407-1. c) Yuletide Pretzel, 8 oz. bag. Recall # F-408-1. d) Chocolate-covered Oreos, sold in bulk. Recall # F-409-1. CODES: All lots. MANUFACTURER: Watsonís candies, Inc., Tonawanda, NY. RECALLED BY: Manufacturer, by letters dated 1/23/01. DISTRIBUTION: Western NY. QUANTITY: Unknown. REASON: The products contained undeclared FD&C Red No.3. _______ PRODUCT: Greek Orzo Salad in 5 lb. bags. Recall # F-426-1. CODE: 11/27,11/29,12/01. MANUFACTURER: Dreamland, Inc., Shoreline, WA. RECALLED BY: Manufacturer, by telephone and visit beginning on 12/01/00. Firm initiated recall is complete. DISTRIBUTION: WA. QUANTITY: 55 - 5 lb. units. REASON: The productís label does not bear a complete ingredient statement. ________ PRODUCT: Candy Express Assorted Sugar Free Chocolates 7.5 oz and 15 oz boxes. Recall # F-427-1. CODES: The lot number for the 7.5 oz. box is 23-22-0 and the sku number for 7.5 oz. box is 80135. The lot number for the 15 oz. box 23-21-0 and the sku number is 80137. MANUFACTURER: Asher Chocolates, Souderton, PA. RECALLED BY: Manufacturer, by telephone on 12/19/00 and by letter on 1/12/01. Firm initiated recall is complete. DISTRIBUTION: MA, NC, NY, OH, PA, and VA. QUANTITY: 308 boxes. REASON: The product, labeled as sugar free chocolates, actually contains regular sweetened chocolates. ________ PRODUCT: Snapple Diet Cranberry Raspberry beverage in 16 ounce glass bottles, 24 btls per case. Recall # F-431-1. CODES: Case code FEB-19-01 RC; Bottle code CT735 19B1. MANUFACTURER: Beverage Capital Corporation, Baltimore, MD. RECALLED BY: Snapple Beverage Group, White Plains, NY, by telephone beginning on 3/15/01. Firm initiated recall is complete. DISTRIBUTION: NY, PA, MD, NH, NJ, DE, CT, MN and MI. QUANTITY: 11457 cases. REASON: Product may be contaminated with mold.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT: Oxygen, USP, Liquid, 196 Liter Dewars (Tanks). Recall # D-230-1. CODE: Lot #: 333F001 Exp. Date 28NOV2001 333F002 28NOV2001 333F003 28NOV2001 334F001 29NOV2001 334F002 29NOV2001 334F003 29NOV2001 340H001 05DEC2001 340H002 05DEC2001 340H002 05DEC2001 341F001 06DEC2001 341F002 06DEC2001 341F003 06DEC2001 MANUFACTURER: BOC Gases, Dayton, OH. RECALLED BY: BOC Gases, Murray Hill, NJ., by telephone on December 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION: OH. QUANTITY: 12 cylinders. REASON: MISBRANDED; Liquid Oxygen DEWAR (TWO LABELS-OXYGEN/NITROGEN) with non-permanent fittings involved in deaths.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
Correction* Recall number D-155-1, as reported in the Enforcement Report of 5/30/01, indicated that Eagle Brand Medicated Oil was manufactured by Anhing Corporation. This was in error. The actual manufacturer was Wilhelm Hauffman and Company, Singapore. ________ PRODUCT: Serostim vial, 6 mg, (somatropin (rDNA origin) for injection, NDC 44087-0006-07, Cartons of 7 units. Recall # D-223-1. CODES: Lot No. MNK612A, Exp 08/02. RESPONSIBLE FIRM AND MANUFACTURER: Unknown. RECALLED BY: C & H Wholesale, Inc., Davie, FL, by letter dated Jan 25, 2001. Firm-initiated recall complete. DISTRIBUTION: NJ and FL. QUANTITY: 36 boxes. REASON: Counterfeit. ________ PRODUCT: Serostim Vial, 6 mg, (somatropin (rDNA origin) for injection), NDC 44087-0006- 07, cartons of 7. Recall # D-224-1. CODES: Lot No: MNK612A. RESPONSIBLE FIRM AND MANUFACTURER: Unknown. RECALLED BY: BERGEN BRUNSWIG DRUG CO., Orange, CA, by recall letter dated March 8, 2001. Firm initiated recall is ongoing. DISTRIBUTION: CA, HI, TX, WA, MD, BUT MOSTLY CA. QUANTITY: 9,998 VIALS. REASON: Counterfeit.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: (Rx) Hydrocortisone and Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle. Recall #D-096-1. EXTENSION. CODES: LOT NO. 22900, 22725, and 22761. Recall Extended to include lots: 22835A, 22997A, 23026A, 23060A, 23097A, 23160A, 23160C, 23246A, 23287A, 23343A, 23419A, 23419C, 23466A, 23474A, 23474C, 23496A, 23497A, 23497C, 23570A, 23601A, 23627A, 23667A, 23667C. MANUFACTURER: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL. RECALLED BY: Manufacturer, by letter on 4/27/2001. Firm initiated recall is ongoing. DISTRIBUTION: Nationwide. QUANTITY: 328,022 units. REASON: DEGRADANTS; OUT OF SPECIFICATION RESULTS DURING STABILITY TESTING. ________ PRODUCT: LotriminÆ AF Spray Liquid, 4 oz. (113 gram) Aerosol can, The product is an OTC, topically applied antifungal aerosol. The active ingredient is 2% Miconazole Nitrate. Recall # D-221-1. CODES: Lot Number 1A05CC. 1A05CCC Exp 01 04. MANUFACTURER: CCL Custom Manufacturing, Inc. Cumberland, RI. RECALLED BY: Schering-Plough HealthCare Products, Cleveland, TN., by letter dated May 22, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 96,500 units (individual cans). REASON: MISBRANDING ; Lotrimin AF Liquid Spray was incorrectly labeled as Lotrimin AF Deodorant Powder. ________ PRODUCT: Z-52 Nighttime Sleep Aid (Diphenhydramine HCI) 50 mg. Tablets. The product is sold in 50 count bottles; one case contained 144 bottles. Recall # D-232-1. CODES: Lot 6072 exp.JAN 02. MANUFACTURER: Nittany Pharmaceuticals, Inc., Milroy PA. RECALLED BY: Manufacturer, by telephone and by letter on 5/18/01. Firm initiated recall is ongoing. DISTRIBUTION: IN. QUANTITY: 144 bottles. REASON: Misbranded; product is labeled with an expiration date having no supporting stability data. ________ PRODUCT: Scot-Tussin Original Clear Five-Action Cold and Allergy Formula SUGAR FREE, 4 FL.OZ. AND 16 FL. OZ bottles. Recall # D-234-1. CODES: Lot Number: 201027. Exp. 10-2002. MANUFACTURER: Scot-Tussin Pharmacal Co., INC., Cranston, RI. RECALLED BY: Manufacturer, by letter dated 3/5/01. Firm initiated recall is complete. DISTRIBUTION: Nationwide. QUANTITY: 4 fl. oz =576 units 16 Fl. oz.=2735. REASON: STABILITY FAILURE FOR SODIUM SALICYLATE COMPONENT. ________ PRODUCT: a) SCOT-TUSSIN ALLERGY Relief Formula Clear SUGAR FREE [OTC Antihistamine] packaged in 4 Fl Oz Bottles. Recall # D-235-1. b) SCOT-TUSSIN SENIOR Clear Sugar Free [OTC Expectorant, Cough Suppressant] Packaged in 4 Fl. OZ. bottles. Recall # D-236-1. CODES: a) Lot Numbers: 980102 and 990121. Exp. Date: 1/2003; b) Lot Number: 970113. Exp. Date: 01/2002. MANUFACTURER: SCOT-TUSSIN PHARMACAL CO., INC. Cranston, RI. RECALLED BY: Manufacturer, by letter dated 5/29/01. Firm initiated recall is complete. DISTRIBUTION: Nationwide. QUANTITY: a) Allergy: 4 oz. =4918 units; b) Senior: 4 oz.=10,166. REASON: a) Allergy Relief tested subpotent for Diphenhydramine. b) Senior tested superpotent for guaifenesin. ________ PRODUCT: Enteric Coated Aspirin Tablets, 325 mg. under the Pharmacist Formula and Hannaford labels in 100 tablet bottles. Recall # D-237-1. CODES: Lot 0A01453. MANUFACTURER: LNK International Hauppauge, NY. RECALLED BY: Leiner Health Products, Inc., Carson, CA, by letter on 5/16/01. Firm initiated recall is ongoing. DISTRIBUTION: FL, IL, MD, ME, VT, VA. QUANTITY: 18,888 bottles. REASON: DISSOLUTION FAILURE (18 MONTH STABILITY). ________ PRODUCT: Pharmacist FormulaÆ Maximum Strength Non-Aspirin Sinus Caplets, (Acetaminophen 500mg/Pseudophedrine HCL 30mg), units of 24. Recall # D-231-1. CODES: LOT NO. OPB1174. MANUFACTURER: Leiner Health Products, Inc., Carson, CA. RECALLED BY: Manufacturer, by letter on 4/19/01. Firm-initiated recall ongoing. DISTRIBUTION: OH. QUANTITY: 6,432. REASON: MISBRANDING: BLISTER STRIPS INCORRECTLY LIST CHLORPHENIRAMINE MALEATE AS AN INGREDIENT. ________ PRODUCT: Indapamide Tablets, USP 2.5 mg, NDC 0172-4259-60 (100 count) and NDC 0172-4259-80 (1000 count)package in bottles of 100 and 1000 tablets. ANDA 74-299. Rx product. Recall D- 238-1. CODES: Lot no. 4259-710. Exp. Date 10/02. MANUFACTURER: Zenith Laboratories Caribe, Inc., Cidra, PR. RECALLED BY: Manufacturer, by letter on 5/30/00. DISTRIBUTION: Nationwide. QUANTITY: 12,334 bottles (100 count) and 1,602 (1000 count). REASON: Illegible monograph on tablets.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall # B-1085-1. CODES: Unit 15011-5925. MANUFACTURER: Blood Systems Inc., Lubbock, TX. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 6, 2000. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 1 unit. REASON: Blood product, which tested negative for anti-HCV, but was collected from a donor who previously tested repeatedly reactive for anti-HCV, was distributed. ________ PRODUCT: Red Blood Cells. Recall # B-1191-1. CODES: Unit 7010136. MANUFACTURER: Community Blood Center of Greater Kansas City, Topeka, KS. RECALLED BY: Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on or about August 19 1999. Firm initiated recall is complete. DISTRIBUTION: KS. QUANTITY: 1 unit. REASON: Blood product, prepared from a Whole Blood unit designated as overweight, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-1210-1. b) Fresh Frozen Plasma Recall # B-1211-1. c) Cryoprecipitated AHF Recall # B-1212-1. d) Recovered Plasma Recall # B-1213-1. CODES: a) Units 9052280, 9068770,9084422,9001352,9019423 b) Unit 9052280 c) Unit 9019423 d) Units (Frozen) 9068770, 9084422, 9001352, Unit (Liquid) 019423. MANUFACTURER: Medic Regional Blood Center, Knoxville, TN. RECALLED BY: Manufacturer, by letter or fax dated April 20.1999. Firm initiated recall is complete. DISTRIBUTION: TN, FL, CA, and Switzerland. QUANTITY: 11 units. REASON: Blood products, which tested negative for anti-HCV, but collected from a donor who previously tested reactive, were distributed. ________ PRODUCT: a) Red Blood Cells, Leukoreduced. Recall # B-1214-1. b) Platelets. Recall # B-1215-1. c) Recovered Plasma. Recall # B-1216-1. CODES: a), b) and c) Unit 6017705. MANUFACTURER: Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY: Manufacturer, by telephone in July, 1997. Firm initiated recall is complete. DISTRIBUTION: OK, TX and Switzerland. QUANTITY: 3 units. REASON: Blood products, collected from a donor with a history of ear piercing within the past 12 months, were distributed. ________ PRODUCT: Corneas. Recall # B-1301-1. CODES: Identification Numbers: NE-01-04-028-L-1 and NE-01-04-028-R-1. MANUFACTURER: New England Eye & Tissue Transplant Bank, A member of the TBI/Tissue Banks International,Boston, MA. RECALLED BY: Manufacturer, by telephone, follow up facsimiles, and letters dated April 26, 2001. Firm initiated recall is complete. DISTRIBUTION: MD and MA. QUANTITY: 2 units. REASON: Corneas, that were collected from a donor who tested repeatedly reactive for the antibody to the human immunodeficiency type 1/2 (HIV-1/2), with a negative test for the HIV-1 p 24 antigen, were distributed. ________ PRODUCT: Corneas. Recall # B-1303-1. CODES: Identification Numbers: # 00-1332 (OS) and # 00-1331 (OD). MANUFACTURER: Lions Eye Bank of Central Texas, St. Davidís Medical Center, Austin, TX. RECALLED BY: Manufacturer, by letters on January 15, 2001 and January 28, 2001. Follow up telephone calls were also held with both transplant physicians in February 2001. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Corneas, that were collected from a donor who tested repeatedly reactive for the antibody to the human immunodeficiency type I/2 (HIV-1/2), with a negative test for the HIV-1 p 24 antigen, were distributed. _______ PRODUCT: a) Red Blood Cells. Recall # B-1323-1. b) Red Blood Cells, Leukoreduced. Recall # B-1324-1. c) Plasma. Recall # B-1325-1. d) Recovered Plasma. Recall # B-1326-1. CODES: a) Units 40FF44135, 40FF43632, 40GV16760, 40FF40931, 40FF40754, 40FF39821; b) Units 40FF47052, 40FF46252, 40FF45822, 40FF45359; c) Units 40FF46252, 40FF45359; d) Units 40FF47052, 40FF45822, 40FF44135, 40FF43632, 40FF40931, 40FF40754, 40FF39821, 40GV16760. MANUFACTURER: American Red Cross Blood Services, Heart of America Region, Peoria, IL. RECALLED BY: Manufacturer, by letters dated November 28, 2000. DISTRIBUTION: IL, MA, TN, PA and Guam. QUANTITY: 20 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: Platelet, Pheresis. Recall # B-1327-1. CODE: Units 29FP60476, 29FP59650. MANUFACTURER: American Red Cross, Mid-Atlantic Regional Blood Services, Norfolk, VA. RECALLED BY: Manufacturing, by letters dated December 19, 2000. Firm initiated recall is complete. DISTRIBUTION: CA and VA. QUANTITY: 1 units. REASON: Blood products, collected from a donor with a history of hepatitis, were distributed. ________ PRODUCT: Source Plasma. Recall # B-1328-1. CODE: Unit NF152439. MANUFACTURER: Sera-Tec Biologicals, Clarksburg, WV. RECALLED BY: Manufacturer, by fax dated March 9, 2000. Firm initiated recall is complete. DISTRIBUTION: Germany. QUANTITY: 1 unit. REASON: Blood product, which was not tested for viral markers, was distributed. ________ PRODUCT: Source Plasma. Recall # B-1334-1. CODE: Unit N-79691-117. MANUFACTURER: Alpha Therapeutic Corporation, Lubbock, TX. RECALLED BY: Manufacturer, by fax transmission dated July 16, 1999, and confirmation of receipt was received on July 20, 1999. Firm initiated recall is complete. DISTRIBUTION: Spain. QUANTITY: 1 unit. REASON: Blood product, that tested negative for antibody to human immunodeficiency virus (anti-HIV-1/2), but was collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, was distributed. ________ PRODUCT: Human Cornea Tissue. Recall # B-1335-1. CODES: Tissue # 01-03-06-A-OS and # 01-03-06-A-OD. MANUFACTURER: Musculoskeletal Transplant Foundation, Cleveland Clinic Foundation, Cleveland, OH. RECALLED BY: Cleveland Eye Bank, Cleveland, OH., by letters dated March 14, 2001, who informed them that the corneas had been transplanted. Firm initiated recall is complete. DISTRIBUTION: OH. QUANTITY: 2 units. REASON: Human corneas, collected from a donor who subsequently tested repeatedly reactive for antibody to the human immunodeficiency virus (anti-HIV-1/2) by another tissue procurement organization, were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
CORRECTION - CLASSIFICATION OF RECALL RECOMMENDATION Upon review, we have determined that our initial classification dated January 23, 2001, was incorrect. This recall has been re-classified as a class III because the possibility of adverse health consequences from the use of the recalled products is considered not likely. Please modify your records to reflect that the correct classification for recall B-780-1 is class III. ________ PRODUCT: Cryoprecipitate. Recall B-923-1. CODE: Unit 2102474. MANUFACTURER: LifeShare, Inc., Elyria, OH. RECALLED BY: Manufacturer, Ohio, by letter dated October 12, 2000. Firm initiated recall is complete. DISTRIBUTION: OH. QUANTITY: 1 unit. REASON: Blood product, collected from a donor with a history of Hemochromatosis, was distributed. ________ PRODUCT: a) Platelets. Recall # B-1174-1. b) Fresh Frozen Plasma. Recall # B-1175-1. CODES: a) and b) Unit 7761685. MANUFACTURER: Carter BloodCare, Bedford, TX. RECALLED BY: Manufacturer, by letters dated August 18, 2000. Firm initiated recall is complete. DISTRIBUTION: TX. QUANTITY: 2 units. REASON: Blood products, prepared from a Whole Blood unit that had discrepant start and end times documented, were distributed. _______ PRODUCT: Platelets, Pheresis. Recall # B-1313-1. CODES: Units V01276, V01277. MANUFACTURER: Community Blood Center of Greater Kansas, Topeka, KS. RECALLED BY: Manufacturer, by letter dated May 14, 1998. Firm initiated recall is complete. DISTRIBUTION: NJ. QUANTITY: 1 unit. REASON: Unlicensed blood products were distributed in interstate commerce. ______ PRODUCT: a) Red Blood Cells. Recall # B-1366-1. b) Recovered Plasma. Recall # B-1367-1. CODES: a) Unit numbers 03LG11549, 03LG11550, 03LG11551, 03LG11552, 03LG11553, 03LG11554, 03LG11555, 03LG11556, 03LG11557, 03LG11558, 03LG11529, 03LG11531, 03LG11532, 03LG11534, 03LG11544, 03LG11545, 03LG11546, and 03LG11547; b) Unit numbers 03LG11529, 03LG11531, 03LG11532, 03LG11534, 03LG11535, 03LG11537, 03LG11544. MANUFACTURER: The American National Red Cross, Southern Region, N.E., Atlanta, GA. RECALLED BY: Manufacturer, by telephone on August 20, 1999, and by letter dated August 27, 1999. Firm initiated recall is complete. DISTRIBUTION: GA and Switzerland. QUANTITY: a) 18 units; b) 7 units. REASON: Blood products, possibly collected in an anticoagulant bag that had exceeded its expiration date, were distributed.RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS III
________ PRODUCT: Bulk Lamb Meal. Recall Number V-052-1. CODES: All lots of bulk lamb meal shipped by the recalling firm. MANUFACTURER: International Proteins Corporations (IPC), St. Paul, Minnesota. RECALLED BY: Manufacturer, sent revised labeling in a letter on April 17, 2001. Firm initiated recall is ongoing. DISTRIBUTION: MN, IL, MO, AK, TX. QUANTITY: 3,094 tons. REASON: The product is not labeled with the required caution statement "Do Not Feed to Cattle or Other Ruminants."END OF ENFORCEMENT REPORT FOR June 20, 2001. ####
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