The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
December 6, 2000 00-49
________ PRODUCT Landshire Supreme Sandwich brand Turkey and Cheese Roll, in 6.30-ounce flexible plastic wrap. Recall # F-056-1. CODE Item Number 003, Lot Numbers: 2410, 2490, 2550. MANUFACTURER Landshire, Inc., Belleville, Illinois. RECALLED BY MANUFACTURER, by memorandum dated September 15, 2000, and by telephone from September 15-19, 2000 followed by visit, and press release issued on September 18, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois, Missouri, Arkansas, Mississippi, Indiana, Iowa, Kansas, Nebraska. QUANTITY 36,751 sandwiches were distributed. REASON The PRODUCT may be contaminated with Listeria monocytogenes. __________ PRODUCT Hood Feature Flavor Peppermint Stick Ice Cream, packaged in half-gallon containers. Recall #F-058-1. CODE September 12, 2001. MANUFACTURER H.P. Hood, Inc., Suffield, Connecticut. RECALLED BY H.P. Hood, Inc., Chelsea, Massachusetts by letter on October 19, 2000, and by press release on October 18, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut, New Hampshire, Massachusetts, Maine, Vermont, Rhode Island, New York. QUANTITY 1,575 cases were distributed. REASON Product contains undeclared egg albumin. ________ PRODUCT Sepp’s Bakery Classic brand Gingerbread Cookies, single serve barnyard shapes: a) Pig, 2.3-ounce (65 gm); b) Tractor, 2.3-ounce (65 gm); c) Cow, 2.3-ounces (65 gm); Recall #F-059/061-1. CODE All products on market at time of recall initiation. MANUFACTURER Sepp’s Gourmet Foods, British Columbia, Canada. RECALLED BY Stop & Shop Supermarket Company, Boston, Massachusetts by E-mail and by press release issued by the manufacturer on October 31, 2000. Firm-initiated recall ongoing. DISTRIBUTION Connecticut, Massachusetts, New York, New Jersey, Rhode Island. QUANTITY 1,170 cases were distributed. REASON Product contains undeclared liquid egg whites.
_______ PRODUCT Saks Fifth Avenue Just Truffles Handmade Chocolates in 13.5-ounce (383g) boxes, 6 boxes per carton. Recall #F-057-1. CODE 000256 and 000258. MANUFACTURER DFG Confectionery, doing business as The Sweet Shop, Fort Worth, Texas. RECALLED BY Manufacturer, by telephone on November 8, 2000, and by letter faxed on November 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 138 cases (6 units per case) were distributed. REASON Product fails to list macadamia nuts as an ingredient. However, the nut is visible on the candy and is also pictured on the product’s label. ________ PRODUCT a) Korn brand Rainbow Cookies, in 15-ounce rigid plastic containers; b) Korn brand French Cookies (with rainbow or chocolate sprinkles), in 15- ounce rigid plastic containers. Recall #F-062/063-1. CODE Not coded. All products on market at time of recall initiation. MANUFACTURER 15th Avenue Food Corporation, also known as Brooklyn, Kosher Bakery, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter May 24, 2000, followed by visit. Completed recall resulted from an inspection by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY a) 100 15-ounce packages; b) 81 15-ounce packages were distributed. REASON a) Product contained undeclared FD&C Yellow No. 5, FD&C Red No.3, FD&C Red No. 40, and FD&C Blue No.1. b) Product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No.3, FD&C Red No. 40, and FD&C Blue No.1. ________ PRODUCT Southern Heaven Creamsicle Fudge, in 4-ounce plastic tubs. Recall #F-065-1. CODE Not coded. All products on market at time of recall initiation. MANUFACTURER Southern Heaven, Depew, New York. RECALLED BY Buffalo Tobacco, Inc., Buffalo, New York, by letter on August 29, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 98 packages. REASON Product contained undeclared FD&C Yellow No. 5 and FD&C Red No. 40. ________ PRODUCT Sweet Shells Candy (dark chocolate with orange crunch) and boxes of assorted chocolates consisting in part of Sweet Shells Candy: a) Sweet Shells Candy in the following size boxes: The Grand Gift Box, 60 pieces, 1 1/4 lbs. (#4700B) Big Box, 30 pieces, 10 oz. (#4700A) Gift Box, 18 pieces, 6 oz. (#4700R) Hostess Box, 8 pieces, 2 1/2 oz.(#4700F) Home Pack, 92 pieces, 1 7/8 lbs. (#4700D) b) Assorted Chocolates in the following size boxes: The 100 Piece Gold Box Assortment, 2 lbs. (#4847) The 72 Piece Assortment, 72 chocolates, 1 1/2 lbs.(#4850) The 48 Piece Assortment, 48 chocolates, 1 lb. (#4841) The Big Gift Assortment, 36 chocolates, 3/4 lb.(#4840) The Gift Assortment, 24 chocolates, 8 1/4 oz. (#4860) Hostess Assortment, 12 chocolates, 4 oz. (#4870) Recall #F-068/069-1. CODE All products on the market at time of recall initiation. MANUFACTURER Harbor Sweets, Inc., Salem, Massachusetts. RECALLED BY Manufacturer, by letter on November 8, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,050 boxes were distributed. REASON Product contains undeclared FD&C Yellow No. 6. ________ PRODUCT Bulk dry soup mixes packaged in plastic bags in cardboard shipping cartons: a) Creamy Chicken Noodle Soup item 741480 - 26 lb. bulk box; b) Corn Chowder Soup item 741520 - 19 lb. bulk box item 171520 - 5 lb. bulk box. Recall #F-070/071-1. CODE Item number 741480, 26 pounds, lot number 10/9/00 Item number 741520, 19 pounds, lot number 10/5/00 Item number 171520, 5 pounds, lot number 10/9/00. MANUFACTURER John B. Sanfilippo & Son, Inc., Elk Grove Village, Illinois. RECALLED BY Manufacturer, by telephone on October 18, 2000, followed by letter on October 19, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Ohio, Kansas, Iowa. QUANTITY 883 pounds were distributed. REASON Products were 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 Lauhoff CCF100 Tiny Flakes packaged in 50-pound bags, used in the brewing industry. Recall #F-072-1. CODE Lot J30K00CJM MANUFACTURER Bunge Lauhoff Grain Company, Crete, Nebraska. RECALLED BY Bunge Lauhoff Grain Company, St. Louis, Missouri, by telephone and fax on November 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania and Wisconsin. QUANTITY 643.5 cwt (hundred weight). REASON Products appear 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 Yellow Corn Flour: MASECA FLOUR: 50 # & Tote Bag Regular #0 Yellow Sam 50 # & Tote Bag Regular #0 Yellow 50 # Regular #1 Yellow 50 # Premium #0 Yellow With CMC 50 # Premium #8 Yellow 50 # Taco Shell #1 Yellow 50 # Chip Delight #4 Yellow 50 # & Tote Bag Chip Delight #6 Yellow 50 # & Tote Bag Taco Shell #6 Yellow 50 # Taco Shell #6 Yellow With Vit. 50 # Tortilla Thin #1 Yellow 50 # Premium #3 Yellow MASA MIXTA 50 # Tortilla #1 Yellow 50 # Tortilla #2 Yellow 50 # Tortilla #3 Yellow 50 # Tortilla #3 (3YS) Yellow 50 # & Tote Bag Tortilla Chip #1 Yellow 50 # Tortilla Chip #55 Yellow 50 # & Tote Bag Corn Chip #4 Yellow 50 # Corn Chip #8 Yellow 50 # Taco #1 Yellow 50 # Taquito #2 Yellow 50 # & Tote Bag Taco #6 Yellow 50 # & Tote Bag Tortilla Chip #9 Yellow Especial 50 # & Tote Bag Tortilla Chip #11 Yellow Especial 50 # Taquito #50/50 Yellow. Recall #F-073-1. CODE All yellow corn flour manufactured since 1/1/00. MANUFACTURER Azteca Milling, Irving, Texas. RECALLED BY Manufacturer, by press release on October 13, 2000, and by letter dated November 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Products may contain StarLink corn, a corn variety which contains Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material necessary for its PRODUCTion in corn. StarLink contains a pesticide that is not allowed for use in foods for human consumption.
________ PRODUCT Wegman’s brand "Food You Feel Good About" Natural Style Apple Juice, in 64-ounce plastic bottles. Recall #F-054-1. CODE Top Line AUG-02-01. Bottom line consists of 4 numbers (military time), followed by the letter A or B or C, followed by CT-095. All lots with the top line are affected. MANUFACTURER Mayer Brothers Apple products, Barker, New York. RECALLED BY Manufacturer, by telephone and by letter dated October 13, 2000. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey, Pennsylvania. QUANTITY 1,582 cases (8 units per case) were distributed. REASON The product is unfit for food due to fermentation and off-taste caused by lactobacillus bacteria. ________ PRODUCT Caffeine Free Dr. Pepper, in 12-ounce cans. Recall #F-055-1. CODE H4H110155 through H4H110330 consecutively where last four digits represent military time of pack on August 11, 2000. code appears on bottom of can. MANUFACTURER Dr. Pepper Bottling Company of Houston, Houston, Texas. RECALLED BY Manufacturer, by visit starting on September 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 8,320 12-packs were distributed. REASON Product contains aspartame and high fructose corn syrup when it should only contain high fructose corn syrup. ________ PRODUCT Balsamic Vinegar of Modena, in 8.5-fluid ounce bottles. Recall #F-064-1. CODE Not coded. All product on market at time of recall initiation. MANUFACTURER Marcello De Nigris, Naples, Italy. RECALLED BY Alanric Food Distributors, Inc., Thorofare, New Jersey, by telephone and visit beginning June 8, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Nationwide. QUANTITY 2,869 bottles were distributed. REASON Product contains undeclared sulfites. ________ PRODUCT Silver Ladle Foods Inc. Stuffed Gourmet Clams, in 15-ounce trays. Recall #F-066-1. CODE 29800 on shipping carton. MANUFACTURER Silver Ladle Soup, Inc., Bridgeport, Connecticut. RECALLED BY Manufacturer, by telephone on October 25, 2000. Firm- initiated recall complete. DISTRIBUTION New York. QUANTITY 64 cases (12 trays per case) were distributed. REASON Product may have been contaminated with filth.
________ PRODUCT Glyburide Tablets, USP (micronized), Rx, indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-deptendent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone: a) Glyburide Tablets, 6 mg, in 100-count bottles, NDC #55370-506-07; b) Glyburide Tablets, 1.5 mg, in 100-count bottles, NDC #55370-146-07. Recall #D-050/051-1. CODE Lot Numbers: a) ST 43001A EXP 3/01; b) TT 2411A EXP 11/00. MANUFACTURER MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico. RECALLED BY Manufacturer, by letter dated October 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,615 bottles were distributed. REASON a) Blend uniformity non-conformance with RSD specification. b) Subpotency.
________ PRODUCT Prednisone 5 mg Tablets, USP, in 100 and 1000-count bottles, 12 bottles per innerpack, and 12 innerpacks per carton, sold under the Mutual label in 1000-count bottles (NDC #53489-138-10), and the URL label in 100-count bottles (NDC #0677-0117-01), intended for endocrine disorders, rheumatic disorders, collagen diseases, dermatological diseases, allergic states, ophthalmic diseases, respiratory diseases, hematological disorders, neoplastic diseases, edematous states, and gastrointestinal diseases. Recall #D-037-1. CODE Lot Numbers: 42129 EXP 12/02 and 42130 EXP 12/02. MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter on October 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 3,857 100-tablet bottless and 6,391 1000-tablet bottles. Firm estimated that 10% of the recalled lots remained on market at time of recall initiation. REASON Blend uniformity failure. ________ PRODUCT Prednisone Tablets, 5 mg, in 1-tablet blister packages, Rx oral glucocorticoid adrenocortical steroid used in the treatment of primary or secondary adrenocortical insufficiency. NDC #51079-032- 19(RR25), Recall #D-038-1. CODE Lot #OH568 EXP 5/02. MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania. RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker), by letter on October 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,076 unit cartons of 25 tablets each were distributed; firm estimated that 30% of the products remained on the market at time of recall initiation. REASON Blend uniformity failure. ________ PRODUCT Prescription Conjugated Estrogen Tablets: a) Premarin (conjugated estrogens tablets), 0.625 mg, in 100-tablet bottles (NDC #0046-0867-81); 1000-tablet bottles (NDC #0046-0867-91); 5000-tablet bottles (NDC #0046-0867-95); b) Premarin (conjugated estrogens tablets), 0.9 mg, in 100-tablet bottles (NDC #0046-0864-81); c) Premarin (conjugated estrogens tablets), 1.25 mg, in 5000-tablet bottles (NDC #0046-0866-95); d) Premarin (conjugated estrogens tablets), 2.5 mg, in 100-tablet bottles (NDC 0046-0865-81); 1000-tablet bottles (NDC 0046-0865-91); e) Premphase 0.625 mg/5 mg tablets (conjugated estrogens/ Medroxyprogesterone acetate), in EZ-dial dispensers (NDC #0046-2573-06). Recall #D-039/043-1. CODE a) 100-tablet bottle Lot #s: 9990085, 9990358, 9990583, and 9990584, EXP dates: September 2002 through December 2003; 1000-tablet bottle Lot #s: 9980880, 9990086 EXP Dates: September 2002 and January 2003; 5000-tablet bottle Lot #s: 9980299, 9981799, 9990290, 9990297, 9990298, and 9990585 EXP Dates: September 2002 through December 2003; b) 100-tablet bottle Lot #s: 9980266, 9980282, 9980649, 9980869, 9981043, 9981044, 9981200, 9981201, 9981497, 9981585, 9981730, 9990074, 9990075, 9990173, 9990174, 9990279, 9990280, 9990281, 9990403, 9990404, 9990405, 9990569, 9990570, 9990571, 9990572, 9990705, 9990958, 9990959, 9990960, 9991012, 9991017, 9991165, 9991283, 9991377 EXP Dates: September 2002 through April 2004; c) 5000-tablet bottle Lot #9980874, EXP February 2003; d) 100-tablet bottle Lot #9990282 EXP October 2003; 1000-tablet bottle Lot #s: 9990175 and 9990283 EXP Dates: October 2003; e) EZ Dial Dispenser: Lot #9990235, EXP June 2001. MANUFACTURER (Responsible Firm) Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New York, and Wyeth Pharmaceuticals Company, Guayma, Puerto Rico. RECALLED BY Wyeth-Ayerst Laboratories, Richmond, Virginia by letter dated October 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Malta. QUANTITY a) 154,977 100-tablet bottles, 27,351 1000-tablet bottles, and 16,348 5000-tablet bottles; b) 2,393,436 100-tablet bottles; c) 2,378 5000-tablet bottles; d) 8,304 100-tablet bottles and 6,256 1000-tablet bottles; e) 41,220 units were distributed. REASON Dissolution Failure. ________ PRODUCT Conjugated estrogen tablets, Rx, repackaged in bottles as follows: a) Premarin(r) Tablets (conjugated estrogens tablets), 0.625 mg, 100- count (NDC 0046-0867-81) & 1,000-count (NDC #0046-0867-91) b) Premarin(r) Tablets (conjugated estrogens tablets), 0.9mg, 90-count bottles. NDC #62584-864-90) c) Premarin(r) Tablets (conjugated estrogens tablets), 1.25mg, 100-count bottles NDC #0046-0866-81 d) Premarin(r) Tablets (conjugated estrogens tablets), 2.5mg, 100-count bottles. NDC #0046-0865-81. Recall #D-044/047-1. CODE Lot Numbers: 8086 EXP 8/6/00; 8482 EXP 9/25/00; 8898 EXP 11/10/00; 8923, EXP 11/13/00; 11210A, EXP 6/28/01; 11210B EXP 7/9/01; 11210C EXP 7/20/01; 11492A EXP 8/10/01; 11492B EXP 8/30/01; 11935 EXP 9/29/01; 12336 EXP 11/16/01; 12878 EXP 2/25/02; 13496 EXP 1/17/02. MANUFACTURER Wyeth-Ayerst Laboratories, Rouses, New York. RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP) (relabeler/repacker/ distributor), by mail and fax on October 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 14,785 bottles were distributed. REASON MANUFACTURER's dissolution failure. ________ PRODUCT Desoximetasone Ointment, USP, 0.25%, in 15 and 60-gram tubes, Rx topical corticosteroid ointment, NDC #0168-0151-15 (15g) and NDC #0168-0151-60 (60g). Recall #D-048-1. CODE Lot #D756 EXP 11/00. MANUFACTURER Altanta, Inc., Hicksville, New York. RECALLED BY Altana, Inc., Melville, New York, by letter dated October 6, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,130 15-gram and 2,135 60-gram tubes were distributed; firm estimated that little or no product remained on market at time of recall initiation. REASON Degradation failure at 12-month stability testing.
________ PRODUCT Source Plasma. Recall #B-281-1. CODE Unit Numbers: 28123613 and 28121978. MANUFACTURER Interstate Blood Bank, Inc. of Chicago, Chicago, Illinois. RECALLED BY MANUFACTURER, by letter dated July 11, 2000. Firm- initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Unsuitable blood products were not properly quarantined. ________ PRODUCT Source Plasma. Recall #B-296-1. CODE Unit Numbers: 0178444 and 0178628. MANUFACTURER Bowling Green Biologicals, Inc., Bowling Green, Kentucky. RECALLED BY Manufacturer, by telephone on August 3, 1998, and by fax on August 4, 1998. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who had been taking an antibiotic. ________ PRODUCT Recovered Plasma. Recall #B-305-1. CODE Unit #7740253. MANUFACTURER Department of Air Force, Lackland AFB, Texas. RECALLED BY Manufacturer, by letter dated January 12, 2000. Firm- initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Platelets Pheresis, Leukocytes Reduced. Recall #B-323/326-1. CODE Unit Numbers: 2001084, 2001090, 2001091, 2001099, 2001100, 2001102, 2001107, 2001110, 2001135, 2001141, 2001146, 2001147, 2001152, 2001156, 2001157, 2001159, 2001163, 2001165, 2001168, 2001173, 2001176, 2001177, 2001178, 2001179, 2001182, 2001184, 2001185, 2001186, 2001187, 2001188, 2001190, 2001194, 2001195; b) 2001086, 2001112, 2001115, 2001121, 2001133, 2001136, 2001137, 2001138, 2001140, 2001143, 2001151, 2001154, 2001181; c) 2001086, 2001090, 2001099, 2001102, 2001107, 2001110, 2001112, 2001133, 2001135, 2001137, 2001138, 2001140, 2001141, 2001143, 2001146, 2001147, 2001151, 2001154, 2001156, 2001159, 2001163, 2001165, 2001170, 2001172, 2001178, 2001179, 2001181, 2001184, 2001188; d) 2001083, 2001114, 2001160, 2001166, 2001183. MANUFACTURER Blood Bank of Delaware, Newark, Delaware. RECALLED BY Manufacturer, by telephone and fax on October 8, 1999, and by letter dated October 14, 1999. Firm-initiated recall complete. DISTRIBUTION Delaware and Maryland. QUANTITY a) 33 units; b) 13 units; c) 29 units; d) 5 units were distributed. REASON Blood products were mislabeled as CMV antibody negative. ________ PRODUCT Platelets, Pooled. Recall #B-328-1. CODE Unit #P00665. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on May 8, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had experienced a life-threatening allergic reaction to a medication. ________ PRODUCT a) Sandoglobulin(r), Immune Globulin Intravenous (Human) 3 Grams lyophilized (single use vial); b) Sandoglobulin(r), Immune Globulin Intravenous (Human) 6 Grams lyophilized (single use vial), Expires AUG 2001. Recall #B-329-1. CODE a) Expires 4/2001 Lot number on vial: 00790-00009 Lot number on outer carton: 009B1935; b) Lot number on vial: 00791-00146 Lot number on outer carton: 146B3971. MANUFACTURER ZLB Central Laboratory, Blood Transfusion Service, Swiss Red Cross, Wankdorfstrasse, Switzerland. RECALLED BY Novartis Pharmaceutical Corporation, East Hanover, New Jersey, by fax and letters on June 6, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a) 7,092 vials; b) 2,969 vials were distributed. REASON Drug products were manufactured in part from the same bulk material used to produce another lot which was rejected because it failed the end product pyrogenicity test. ________ PRODUCT Recovered Plasma. Recall #B-341-1. CODE Unit #8600650. MANUFACTURER Poudre Valley Health Care, Inc., Fort Collins, Colorado. RECALLED BY Manufacturer, by letter dated April 7, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but was collected from a donor who previously tested repeatedly reactive for anti-HIV-1. ________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f) Fresh Frozen Plasma; g) Plasma, Frozen; h) Recovered Plasma. Recall #B-353/360-1. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER The American National Red Cross, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated June 2 and 3, 1999, and July 8, 1999. Firm-initiated recall ongoing. DISTRIBUTION Wisconsin, Iowa, Michigan, Illinois, Florida, Alabama, California, Georgia, Idaho, Massachusetts, Missouri, Nebraska, Puerto Rico, Ohio, Tennessee, West Virginia, , Switzerland. QUANTITY a) 1 unit; b) 149 units; c) 68 units; d) 20 units; e) 14 units; f) 30 units; g) 2 units; h) 128 units were distributed. REASON Blood products tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1.
________ PRODUCT Platelets, Pheresis. Recall #B-318-1. CODE Unit #LP07164. MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee. RECALLED BY Manufacturer, by letter dated January 6, 1997. Firm- initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning a post donation illness.
________ PRODUCT AMK Single Step Patella Replacement Basket Instrument (26 mm), Catalog #2500-29-000, an orthopaedic manual surgical instrument intended to be used to cut or shape the patella bone to allow placement of the AMK patella prosthesis, a component of the AMK total knee replacement system. Recall #Z-020-1. CODE Lot #U31EF1000. MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by visit on September 21, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit. REASON The device was incorrectly labeled as sterile when it was not properly sterilized. ________ PRODUCT Rapid Form Vacuum Immobilizer: a) Rapid Form Vacuum Immobilizer 2-piece set, stock #013490 containing 2 splints and 1 pump per set; b) Rapid Form Vacuum Immobilizer 3-piece set, stock #013463 containing 3 splints and 1 pump per set; c) Rapid Form Pump item #013467. Recall #Z-068/070-1. CODE a) Lot LLF246 and LLG320; b) Lot LLF246; c) None. MANUFACTURER Cramer products, Inc., Gardner, Kansas. RECALLED BY Manufacturer, by mail on August 23-24, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 321 2-piece sets; b) 40 3-piece sets; c) 22 replacement pumps were distributed. REASON Some incorrect pumps were inadvertently included in splint kits or sent out as replacement pumps.
________ PRODUCT Roche Creatinine Mira, Catalog #3033414, intended for use on the COBAS MIRA analyzer for the kinetic quantitative determination of creatinine in serum or urine. Recall #Z-071/072-1. CODE Lot #A12071 EXP 9/30/02. MANUFACTURER Raichem, Division of Hemagen, San Diego, California. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter on September 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2550 units. REASON 1. The package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735. 2. The device may produce falsely elevated creatinines dues to elevated trigliycerides in the serum samples. ________ PRODUCT a) Vitros 950 Chemistry System; b) Vitros 950AT Chemistry System. Recall #Z-073/074-1. CODE a) Serial Number less than 09501559; b) Serial Number less than 09600129. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter February 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 1,420; b) 30 units were distributed. REASON An atypical pattern in relationship between slide millivold used to calculate a predicted concentration and the millivolt reading used to assess the slide impedance. ________ PRODUCT Immunosimplicity brand Is anti-ds DNA Test Kit (ONLY the Positive control, lot #60600 is under recall, the kit cannot be used without the positive control), Catalog #720700, an in-vitro diagnostic reagent kit. Recall #Z-076-1. CODE Lot #60600, EXP 6/01. MANUFACTURER Diamedix Corporation, Miami, Florida. RECALLED BY Manufactuer, by letter on September 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Tennessee, Florida, Pennsylvania, Virginia, California, Ohio, Missouri, Georgia, Hawaii, Illinois, Costa Rica, Italy. QUANTITY 137 units were distributed. REASON Failure of the Positive Control from this lot number kit, to recover within its assigned labeled range. ________ PRODUCT Roche COBAS Integra Analyzer Operators: a) Cobas Integra 400, Catalog #1045199; b) COBAS Integra 700, Catalog #1044826; c) COBAS Integra 700, Catalog #1046926. Recall #Z-077/079-1. CODE All serial numbers. MANUFACTURER Tegimenta AG, Roche Diagnostics Instrument Center, Rotkreuz, Switzerand. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by customer bulletin issued on May 15, 2000, and urgent product correction notice issued on September 28, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 399 analyzers. REASON Device reagent cassettes previously used on a Cobas Integra analyzer can be interchanged on another Cobas Integra analyzer and that analyzer will treat the used cassette as a new cassette. Under such circumstances the instrument could sample the reagent at the wrong level leading to erroneous results, and could incorrectly reconstitute and/or dispense reagents. ________ PRODUCT Vascular prostheses: (a) C.R. Bard's Impra Flex(tm) Grafts with small beading; (b) Distaflo(tm) Bypass Grafts. Recall #Z-083/084-1. CODE a) Catalog Nos. F1006TWS, F3006TWSC, F310086TWS, F310086TWSC, F5006S, F5006SC, F5006TWS, F5006TWSC, F5008S, F5008TWS, F5008TWSC, F6006TWS, F6006TWSC, F7004TWS, F7005TWS, F7005TWSC, F7006S, F7006SC, F7006TWS, F7006TWSC, F7007TWS, F7007TWSC, F7008S, F7008SC, F7008TWS, F7008TWSC, F70N75TSC, F70N75TWS, F70T7-4S, F70T74TSC, F70T74TWS, F70T8-5S, F70T85TWS, F8006S, F8006SC, F8006TWS, F8006TWSC, F8007TWS, F8007TWSC, F8008S, F8008SC, F8008TWS, F8008TWSC. b) Catalog Nos. DF5006SC, DF5007SC, DF6006SC, DF6007SC, DF7006SC, DF5007SC, DF8006SC, DF5007SC. MANUFACTURER Impra, Inc., Tempe, Arizona. RECALLED BY Manufacturer, by letters in May 1999, and August 2000. Firm-initiated recall ongoing. DISTRIBUTION Canada, New Zealand, Korea, Brazil, Australia, Peru, Japan, Belgium. QUANTITY 4,270 units were distributed. REASON The United Kingdom (UK) required the firm to provide better instructions for use to caution the physicians when removing the beading. The UK required the firm to perform a market withdrawal to resolve this problem. ________ PRODUCT Olympus EVIS-Endoscopic Video Image and Data Systems for examination of the gastrointestinal tract and colon: a) Olympus Gastrointestinal Fiberscope GIF-2T20; b) Olympus Gastrointestinal Videoscope GIF-2T100. Recall #Z-092/093-1. CODE a) Olympus Gastrointestinal Fiberscope Model GIF type 2T20 (GIF-2T20), Reprocessing Manual Part Number GR2180. Serial Numbers of affected endoscopes: 2811017, 2811025, 2811028, 2811031, 2811034, 2811035. b) Olympus Gastrointestinal Videoscope Model GIF type 2T100 (GIF-2T100), Reprocessing Manual Part Number GR2180. Serial numbers of affected endoscopes: 2861291-2861298, 2861300-2861304, 2861306-2861314, 2861316- 2861337, 2861339-2861341, 2861344-2861356, 2861358-2861363, 2861365- 2861379, 2861383-2861384, 2861386-2861396, 2861398-2861405, 2961406, 2961408-2961423, 2961425-2961426, 2961429-2961431, 2961433-2961437, 2961440-2961458, 2961460- 2961462, 2961464, 2961466-2961470, 2961472- 2961492, 2961495-2961500, 2961502-2961516, 2961519. MANUFACTURER Olympus Opto-Electronics, Ltd. -Aizu Factory, Moden-machi, Fukushima-Ken Japan. RECALLED BY Olympus America, Inc., Melville, New York, by letter dated March 8, 2000. Firm-initiated recall complete. DISTRIBUTION a) Alabama, Rhode Island, Louisiana, Hawaii, Chile, Peru; b) Nationwide and international. QUANTITY a) 6 units; b) 198 units were distributed. REASON The labeling instructions for reprocessing both the two suction channel openings as well as the suction switchover lever do not provide enough detailed information regarding reprocessing of this feature and accessory. END OF ENFORCEMENT REPORT FOR DECEMBER 6, 2000. ####
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