February 5, 1997 97-06 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Pepperidge Farm Snack Mixes: (a) Pepperidge Farm Gold Fish Fat Free Pretzel Mix, 9-1/4 ounces and 1.5 ounces; (b) Pepperidge Farm Gold Fish Seasoned Snack Mix, 9-1/4 ounces; (c) Pepperidge Farm Savory Gold Fish Snack Mix, 32 ounces. Recall #F-231/233-7. CODE For product with net weight of 9 1/4 ounces, all product manufactured on before 9/25/96 with an expiration date on or before 2/15/97. For the product with net weight of 1.5 ounces, all product with an expiration date on or before 3/1/97. For product with net weight of 32 ounces, all product with expiration date on or before 3/22/97. MANUFACTURER Pepperidge Farm, Willard, Ohio. RECALLED BY Pepperidge Farm, Norwalk, Connecticut, by press release on November 22, 1996, and by fax followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY (a) 388,416 cases (9-1/4 ounces) and 73,020 cases (1-1/2 ounces); (b) 433,704 cases; (c) 68,190 cases were manufactured. REASON The products may contain undeclared peanuts. _______________ PRODUCT Candy Advent Calendar, "24 Day Christmas Countdown". Recall #F-234-7. CODE None. MANUFACTURER Product of Poland. RECALLED BY Morris National Company, Inc., Azusa, California, by letter on December 12, 1996, and by press release on December 17, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 150,000 consumer units were distributed. REASON Product contains undeclared peanut protein. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Aredia (Pamidronate Disodium) For Injection, 60 mg vials, Rx indicated for the treatment of patients with moderate hypercalcemia associated with malignancy in conjunction with adequate hydration. Recall #D-087-7. CODE Lot #1000500 EXP 3/97. MANUFACTURER Ciba Pharmaceuticals, Summit, New Jersey. RECALLED BY Manufacturer, by fax on May 10, 1996, followed by letter sent on May 15, 1996. Firm- initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 750 vials were distributed. REASON Product label mix-up. Some unit carton labels may show two different strengths, 90 mg and 60 mg (correct). _______________ PRODUCT Sus-Phrine, Epinephrine Injectable Suspension, 5 mg/ml, in 0.3 ml ampules, Rx indicated for use for the symptomatic treatment of bronchial asthma, and reversible bronchospasm associated with bronchitis and emphysema. Recall #D-091-7. CODE Lot numbers: 95A751 EXP 1/98 (10 per box), 95E030 EXP 5/98 (10 per box), 95E550 EXP 6/98 (25 per box). MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. -2-RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter dated December 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 12,772 boxes were distributed. REASON Some packages may be moldy. _______________ PRODUCT Bristol Myers Squibb's OVCON35 - 28 Day (Norethindrone and Ethinyl Estradiol Tablets, USP), Rx oral contraceptive packaged as 28-day regimen with 21 active ingredient tablets and 7 inactive (placebo) tablets in a blister strip compact. Recall #D-096-7. CODE Lot #H6J272A EXP 8/98. MANUFACTURER Bristol Laboratories, Corporation, Mayaguez, Puerto Rico. RECALLED BY Bristol Myers Squibb Company, New Brunswick, New Jersey, by letter dated January 15, 1997, followed by a revised letter dated January 18, 1997, and by press release on January 17, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 25,056 cartons (6 compacts/carton) were distributed. REASON Contraceptive tablets are out of sequence (the seven inactive tablets were mistakenly packaged to be taken the first seven days of the 28-day cycle instead of the last seven days). RECALLS AND FIELD CORRECTIONS: DRUGS --- CLASS III ========= _______________ PRODUCT Extra Strength Tylenol (Acetaminophen) Gelcaps, 500 mg, in bottles of 50, 100, or 300, OTC pain reliever/fever reducer. Recall #D-083-7. CODE Lot numbers: SPA 664 (50s), SPA 745 (100s), SPA 751 (300s). MANUFACTURER McNeil Consumer Products Company, Las Piedras, Puerto Rico. RECALLED BY McNeil Consumer Products Company, Fort Washington, Pennsylvania, by letter dated December 27, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 339,912 bottles of lot SPA 664; 96,240 bottles of lot SPA 745; 7,272 bottles of lot SPA 751 were distributed. REASON Microbial contamination of non-sterile product (gelatin coating exceeded internal specification for aerobic microorganisms). -3-_______________ PRODUCT Leucovorin Calcium Tablets, Rx oral derivative of folic acid: (a) 5 mg; (b) 25 mg. Recall #D-088/089-7. CODE Lot numbers: 6B107, 6H428, 6S162. MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey. RECALLED BY UDL Laboratories, Inc., Rockford, Illinois, by letter dated January 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (a) 2,614 unit cartons: (b) 180 unit cartons were distributed; firm estimated that 40% of the 5 mg and 75% of the 25 mg product remained on market at time of recall initiation. REASON The particle size range of the bulk active ingredient is outside the normal range and could cause the product to fail the content uniformity test. _______________ PRODUCT E-Z-EM brand Liquid Polibar, Barium Sulfate Suspension, in 64 fluid ounce bottles, Rx product for use as radiological contrast media for upper and lower gastrointestinal procedures by conventional x-ray or computed tomography. Recall #D-090-7. CODE Catalog Number L164, Lot numbers: 1B8687, 1B8688 and 1B8689 EXP 1/97. MANUFACTURER Therapex, Division of E-Z-EM Canada, Inc., Quebec, Canada. RECALLED BY E-Z-EM, Inc., Westbury, New York, by letter mailed on December 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 367 cases of lot 1B8687; 402 cases of lot 1B8688, 318 cases of lot 1B8689 (4 bottles per case) were distributed. REASON Product is not stable (failed total solids and barium content assays on stability). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-127-7. CODE Unit #21FJ04987. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated July 5, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. -4-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-278/280-7. CODE Unit #355950. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letters dated May 9, 1996 and June 3, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina, Florida, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within 12 months of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Cryoprecipitated AHF; (e) Single Donor Plasma; (f) Fresh Frozen Plasma, for further manufacture; (g) Source Leukocytes; (h) Recovered Plasma. Recall #B-298/305-7. CODE Unit numbers: (a) 9537728, 9633605, 8965252, 8980568, 9012160, 9027003, 9076560, 9137112, 9137513, 9185851, 9207443, 9342867, 9630976; (b) 9633605, 8980568, 9012160, 9027003, 9692638, 9630976; (c) 8965252, 9038149, 9342867; (d) 9692638, 9630976; (e) 9692638; (f) 8880628, 8934808, 8980568, 9012160, 9027003, 9076560, 9137112, 9137513, 9207443; (g) 9185851; (h) 9407336, 9537919, 9630976. MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated May 2, 1996. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Massachusetts, Kentucky, Indiana, Texas, Illinois, Florida. QUANTITY (a) 13 units; (b) 6 units; (c) 3 units; (d) 2 units; (e) 1 unit; (f) 9 units; (g) 1 unit; (h) 3 units were distributed. REASON Blood products tested negative for the hepatitis B surface antigen (HBsAg), but were collected from donors who previously were confirmed positive for HBsAg. _______________ PRODUCT Source Plasma. Recall #B-307-7. CODE Unit #65211151. MANUFACTURER Simi Biological Resources, Inc., Tacoma, Washington. RECALLED BY Manufacturer, by letter dated May 15, 1996. Firm-initiated recall complete. DISTRIBUTION California. -5-QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of high risk behavior. ______________ PRODUCT Source Plasma. Recall #B-308-7. CODE Unit numbers: 58526811, 58528228, 59008552, 59009740. MANUFACTURER Simi Biological Resources, Inc., Fort Smith, Arkansas. RECALLED BY Manufacturer, by letter dated January 5, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 4 units were distributed. REASON Blood products were collected from a donor who reported a history of high risk behavior. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-309/310-7. CODE Unit #28LQ10807. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY Manufacturer, by telephone on September 27, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit of each component. REASON Blood products, corresponding to a unit of Platelets which was positive for coagulase negative Staphylococcus, were distributed. _______________ PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall #B-314/315-7. CODE Unit #32KF06807. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated March 11, 1996. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-317/320-7. CODE Unit numbers: (a) 32G82080, 32G96920, 32H96969, 32H38140, 32H21662; (b) 32G82080, 32G96920, 32H96969, 32H38140; (c) 32H38140; (d) 32G82080, 32G96920, 32H96969, 32H21662. -6-MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated October 23, 1995 or November 8, 1995, or by fax in February 1995. Firm-initiated recall complete. DISTRIBUTION Wisconsin, California, New York. QUANTITY (a) 5 units; (b) 4 units; (c) 1 unit; (d) 4 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), were collected from donors who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-321/322-7. CODE Unit numbers: 32T07129 and 32T07981. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated December 28, 1994, and by fax on December 30, 1994. Firm- initiated recall complete. DISTRIBUTION Iowa and California. QUANTITY 2 units of each component were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot indeterminate. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-327/329-7. CODE Unit #2430544. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis. RECALLED BY Manufacturer, by letter dated July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, New Jersey, Indiana. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within 12 months of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered Plasma. Recall #B-330/332-7. CODE Unit numbers: (a&c) 51J17595; (a&b) 51F02583. -7-MANUFACTURER American Red Cross Blood Services, Wichita, Falls, Texas. RECALLED BY Manufacturer, by letters dated November 3 and 6, 1995, and December 18, 1995. Firm- initiated recall complete. DISTRIBUTION Texas, California, Oklahoma. QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were subjected to additional retesting. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Red Blood Cells. Recall #B-109-7. CODE 21GF72818, 21GF72831, 21GF72924, 21GF72925, 21GF73026. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated April 15, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state, Oregon. QUANTITY 5 units were distributed. REASON Blood products were not refrigerated within eight hours of collection. _______________ PRODUCT Whole Blood. Recall #B-295-7. CODE Unit #32V23921. MANUFACTURER American Red Cross Blood Services, Green Bay, Wisconsin. RECALLED BY Manufacturer, by telephone on September 6, 1995. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-296/297-7. CODE Unit #29133-0975. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letters dated August 29, 1996, and October 28, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. -8-REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc) were collected from a donor who previously tested repeatedly reactive for anti HBc. _______________ PRODUCT Whole Blood. Recall #B-306-7. CODE Unit #33LL21501. MANUFACTURER American Red Cross Blood Services, Farmington, Connecticut. RECALLED BY Manufacturer, by letter dated September 13, 1995. Firm-initiated recall complete. DISTRIBUTION Connecticut. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-311/313-7. CODE Unit #53M03313. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letters dated January 29, 1996, and November 26, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland, Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested reactive for anti- HIV-1, Western blot negative. The donor has since met reentry. _______________ PRODUCT Recovered Plasma. Recall #B-316-7. CODE Unit #32KF06807. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by fax on March 12, 1996. Firm- initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. -9-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT MinXray Mobile/Portable General Purpose Podiatry Systems, used in general purpose radiographic studies: (a) Model No. PM200 Mobile/Portable Podiatry Systems manufactured before August 9, 1993, but introduced into commerce outside the date of limitations specified by Variance No. 94V-0003; (b) Model No. PW200 Mobile/Portable Podiatry Systems manufactured before August 9, 1993, but introduced into commerce outside the date of limitations specified by Variance No. 94V-0003. Recall #Z-015/016-7. CODE Units manufactured prior to August 9, 1993, but shipped subsequent to that date in violation of Variance No. 94V-0003 Model PM200: tubehead s/n 16645, 16646, 16648, 16649, 16651 Model PW200: tubehead s/n 16650. MANUFACTURER Mikasa X-ray Co. Ltd., Tokyo, Japan. RECALLED BY MinXray, Inc., Northbrook, Illinois. FDA approved the firm's corrective action plan October 22, 1996, and by end user notification letters sent on January 15, 1997. Firm- initiated field correction ongoing. DISTRIBUTION New Jersey, New York, Pennsylvania, Indiana, Ohio. QUANTITY 6 units. REASON The diagnostic x-ray devices failed to comply with the Federal Performance Standard for Diagnostic X-Ray Systems and their major components for light illuminance and failed the edge contrast ratio required. _______________ PRODUCT VSI Sigmoidoscope Endosheaths, (sterile, single use): (a) SS-V32 EndoSheath for use with the S-V100 Video Sigmoidoscope, Catalog No. 06-7101; (b) SS-F32 EndoSheath for use with the S-F100 Fiber Optic Sigmoidoscope, Catalog No. 06-2101. Recall #Z-199/200-7. CODE Product shipped prior to 11/12/96. MANUFACTURER Vision Sciences, Inc., Natick, Massachusetts. RECALLED BY Manufacturer, by letter dated November 14, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 23,568 units were distributed. REASON Hairline cracks were found at the corners of the tray under the sealing flange, therefore compromising the sterility of the devices. -10-_______________ PRODUCT Undercover 1,000 cc Urine Collection Bag (The Original Belly Bag). Recall #Z-203-7. CODE Catalog #B-1000, Lot #A-8640. MANUFACTURER North American Medical, Inc., Lubbock, Texas. RECALLED BY Manufacturer, by letter dated November 21, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,860 units were distributed. REASON An inadequate seal was found on the device packaging, therefore compromising the sterility of the device. _______________ PRODUCT Olympus Remote Switch Model No. MH-965, designed to be connected to the Olympus Camera Control Unit OTV-S5C, and used in combination with any OTV-S5 System Camera Heads or an OES Laparo-Thoraco Videoscope. This provides the endoscopist fingertip control of the VTR operation or shutter release for still photography using the EVIS Monitor Photo unit SCV-3 or the Olympus Color Video Printer OEP. Recall #Z-234-7. CODE All lots. MANUFACTURER Olympus Japan, Inc., Shirakawa, Japan. RECALLED BY Olympus America, Inc., Melville, New York, by letter dated October 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION Arizona, Texas, Maryland, Florida, Georgia, California, Illinois, Michigan, Oregon, Pennsylvania. QUANTITY 94 switches were distributed. REASON The Color Bars are inadvertently displayed on the monitor screen, when the MH-965 remote switch for the OTV-S5 is used in conjunction with an active cord from an unipolar accessory. _______________ PRODUCT Quinton Instrument Stress Test Monitors: (a) Model No. Q3000 Monitor; (b) Model No. Q4000 Monitor; (c) Model No. Q4000K Monitor. Recall #Z-235/237-7. CODE All serial numbers. MANUFACTURER Quinton Instrument Company, Bothell, Washington. RECALLED BY Manufacturer, by letter beginning on January 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY (a) 3,196 units; (b) 2,079 units; (c) 1,682 units were distributed. -11-REASON A software anomaly could cause their treadmills to erroneously increase or decrease in speed, and/or grade when the "Stop EXER" key is pressed at the end of a stage. _______________ PRODUCT Neisseria Meningitides Polyvalent (Group A-D) Agglutinating Serum, in-vitro diagnostic test kit which consists of one 2 ml vial of product. Recall #Z-239-7. CODE Product Code ZM33, Lots K442010*, K262110, K846210, K255210* (*only distributed in United States.) MANUFACTURER Murex Biotech, Ltd., Temple Hill, Dartford, England. RECALLED BY Murex Diagnostic, Inc., Norcross, Georgia, by telephone, followed by letter dated April 3, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 28 kits were distributed REASON The subject lots will not detect N. meningitides Group B, due to activity deterioration. _______________ UPDATE Kangaroo Entriflush Enteral Feeding Pump, Catalog #8884-352405 and #8884-352413, manufactured by Sherwood Davis & Geck, which appeared in the January 29, 1997, Enforcement Report should read: CODE: All pumps distributed between November 1, 1995 and November 22, 1996. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Ferris PolyMem Membrane Dressing, 3" x 3" Sterile Pad, a non-adhesive sterile wound dressing. Recall #Z-238-7. CODE Product #5033, Lot #27696E1. MANUFACTURER Ferris Manufacturing Corporation, Burr Ridge, Illinois. RECALLED BY Manufacturer, by letter dated November 12, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and The Netherlands. QUANTITY 62 cases were distributed. REASON Some of the pouches were mislabeled as, "Ferris PolyMem 2" x 3" dressings with transparent adhesive film borders, Product No. 405". -12-RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ======== _______________ PRODUCT Veterinary Chorionic Gonadotropin for Injection, USP, 10,000 units per sterile 10 ml multiple dose monovial, under the Steris Laboratories and The Butler Company labels. Recall #V-026-7. CODE Codes: Lot numbers: 94C050, 94D160, 94L470, 95D640, 95F100, 95G570, 95H930, 97J230. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona RECALLED BY Manufacturer, by letter dated May 17, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 34,000 vials were distributed. REASON Silicon particulate matter in vials. _______________ PRODUCT Veterinary vitamin injectable "B" Complex with C and B12 Injection, (10 mL multiple dose monovial), under Steris Laboratories, A & G Pharmaceuticals and The Butler Company labels. Recall #V-027-7. CODE Lot numbers: 93K090, 93K360, 94A320, 94B470, 94C240, 94E080, 94J370, 94K430, 94L560, 95A310, 95A430, 95A820, 95B660, 95B970, 95C860, 95E540, 95G700, 95G890. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated April 17, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 31,500 vials were distributed. REASON Stability data does not support labeled expiration dates. -13- END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for