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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Pasteurized liquid whole eggs Lots #195-0 and #196-0 Class I Pasteurized liquid whole eggs tested positive for Salmonella. Ballas Egg Prod Corp
Biologics Skin NLGIN100008001, NLGIN100008002, NLGIN100008013, NLGIN100008014, NLGIN100008015, NLGIN100008016, NLGIN100008017, NLGIN100008003, NLGIN100008004, NLGIN100008005, NLGIN100008007, NLGIN100008008, NLGIN100008009, NLGIN100008012, NLGIN100008018, NLGIN100008019, NLGIN100008020, NLGIN100008021, NLGIN100008022, NLGIN100008023, NLGIN100008025, NLGIN100008006, NLGIN100008010, NLGIN100008011, NLGIN100008024 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. New Life Generation, INC.
Veterinary Sportsman's Choice, RECORD RACK, DEER CORN (LL), 10263 LL, NET WEIGHT 40 LB (18.14 kg), CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304239992 4K1213 - 4K1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary DEER CORN (LL), 5692 LL, NET WEIGHT 50 LB (22.67 kg), CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304009519 4K1213 - 4K1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Sportsman's Choice, RECORD RACK, 20% DEER PELLET (LL), 3573 LL, NET WEIGHT 40 LB (18.14 kg), CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304200176 4K1213 - 4K1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Sportsman's Choice, RECORD RACK, TEXTURED BREEDER 18 (MN), 45044 MN, NET WEIGHT 50 LB (22.67 kg) BAG, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304245078 4K1213 - 4K1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, ALL GRAIN 12% (LL), 7507-A LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304259693 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary DUMOR (R) EQUISTAGES (TM) HORSE FEED (LL), 93925 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394003883 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary DUMOR (R) PLEASURE HORSE 12% TEXTURED (LL), 93917 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394057428 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary FRIENDS EQUINE 12 (LL), 2859 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304221799 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary FRIENDS 12-5 PELLETS (LL), 5995 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304237745 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), LIFE DESIGN MARE & FOAL (LL), 1307 LL, NET WEIGHT ON BAG OR BULK, and 1307-BK LL, (BULK), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304004279 (BULK HAS NO UPC) 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Prime Quality MATTHEWS 14% HORSE PELLET (LL), 338018 LL, NET WEIGHT ON BAG OR BULK, PRIME QUALITY FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304243180 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE (R) 10% DRY TEXTURE HORSE FEED (LL), 93921 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394017026 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, 12% HORSE SWEET (LL), 7512 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304253189 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), VITALITY (R) MARE & FOAL, 7139 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304235796 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), VITALITY (R) PERFORM 12% (LL), 7133 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304235772 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), VITALITY (R) PERFORM 14% (LL), 7136 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304253826 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), TRIUMPH (R) 12 PELLETS (LL), 7189 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304251079 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), TRIUMPH (R) COMPLETE (LL), 7192 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304251109 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), TRIUMPH (R) 14 SWEET HORSE FEED (LL), 7193 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304252199 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), TRIUMPH (R) 14 PELLETED HORSE FEED (LL), 7198 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304252175 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Life Design PRIME 10 (LL), 1310 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304004293 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Life Design PRIME 12 (LL), 1312 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304004309 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Life Design COMPLETE 10% (LL), 1309 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304041397 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Life Design COMPLETE (LL), 1308 LL and 1308-BK LL, (BULK), NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304004286 and UPC 722304282059 (BULK) 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Life Design SENIOR HORSE FEED (LL), 7550 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304007140 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), LEGACY COMMERCIAL (LL), 60103-C LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304275334 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary FEED PRO 10-10-10 (LL), 9542 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304247386 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary HIGH FAT PERFORMANCE PELLET (LB) 205736 LB (22.67 kg) OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304269364 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), COUNTRY FEEDS (R) LAYER 16% CRUMBLES (LL), 95172 LL, NET WEIGHT 50 LB (22.67 kg), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, No UPC 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), COUNTRY FEEDS (R) LAYER 16% PL (LL), 95180 LL, NET WEIGHT 50 LB (22.67 kg), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, No UPC 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), COUNTRY FEEDS (R) SCRATCH GRAINS (LL), 95174 LL, NET WEIGHT 50 LB (22.67 kg), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304275860 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary DUMOR (R) POULTRY LAYER 16% PL (LL), 93973 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749694951136 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary DUMOR (R) POULTRY LAYER 16% CR (LL), 93976 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394057381 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary JORDAN LAYER 190 (LL), 2672 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304220532 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary JORDAN LAYER 200 W/SHELL PACK (LL), 4055-SH LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 72230422045 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary JORDAN LAYER 220 (SHELL PACK) (LL), 2359-SH LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304220501 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary JORDAN LAYER REFRESH PHASE 1 (LL), 6714 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304249182 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary ACCO FEEDS (R) Showmaster (R) BROILER/TURKEY FINISHER EXTRUDED (LL), 11044 LL, NET WEIGHT ON BAG OR BULK, ACCO FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304261511 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE HOG FEED PL (LL), 93962 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394950163 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, 10% MULTI SPECIES SWEET (LL), 7504 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304252120 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NATUREWISE(R) CRICKET & EARTHWORM FEED (HI CAL) (LL), 91823 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304217846 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NATUREWISE(R) RABBIT PELLETS 16 (25#) (LL), 91972 LL, WEIGHT 25 LB (11.33 kg), UPC: 722304029210 and (50#) (LL) 91974 LL, NET WEIGHT 50 LB (22.67 kg), UPC: 722304029074, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NATUREWISE(R) CRACKED CORN (25#) (LL) 91868-25 LL1006, NET WEIGHT 25 LB (11.33 kg), UPC: 722304029036 and 91868 LL1006 NET WEIGHT 50 LB (22.67 kg), UPC: 72230429036, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440 4K1213 - 4K1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, 12% MULTI-SPECIES SWEET (LL), 7502 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304252106 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, 10% MULTI-SPECIES SWEET (LL), 7504 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304252120 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary 12% HI FAT ALL STOCK (LL), 9541 LL, NET WEIGHT ON BAG OR BULK and 9541-BK, BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304247362 and UPC 722304247386 (BULK) 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary 12% PREMIX PELLET (LL), 7137 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304251796 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary WRANGLER 10 SWEET (LL), 95300 LL, NET WEIGHT 50 LB (22.67 kg) OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304283995 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE (R) 10% SWEET FEED TXT (LL), 93916 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394950583 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE (R) 12% SWEET FEED TXT (LL), 93922 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394950583 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE (R) ALL STOCK SWEET FEED (LL), 93933 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, BRENTWOOD, TN 37027 UPC 749394016340 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NutreBeef (R), 14% AN CREEP PELLET (LL), 93912 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304271077 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NutreBeef (R), SUPER BEEF (LL), 92102 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304261412 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), Stock & Stable, 12 PMP (LL), 7502_P LL, NET WEIGHT 50 LB (22.67 kg) OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304282226 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary SKLAR RANGE MEAL (LL), 4442 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304075675 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary JR. SKLAR BULL RATION (LL), 4445 LL, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304075668 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary COMMODITY 14 (LL), 151016-A LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304254384 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), COUNTRY FEEDS (R) CHICK STARTER GROWER 18% CRUMBLES (AMP) (LL) MEDICATED, 95171-A LL, NET WEIGHT 50 LB (22.67 kg), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC None 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NutreBeef (R), RANGE MEAL (C70) (LL) MEDICATED, 93908LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304273767 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NATUREWISE GOAT PELLETS 16 (DQ) (LL), 91705-D LL, MEDICATED, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304031640 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), PORKTRACK(R) SOW/PIG COMPLETE PL 16 (C50) (LL) MEDICATED, 90679-C LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304017200 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary ACCO FEEDS (R) SHOWMASTER (R) GOAT DEVELOPER (DCX) (LL) MEDICATED, 10601-D LL, NET WEIGHT 50 LB (22.67 kg) OR BULK, ACCO FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304235536 4K1213 - 4K1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary 14% HI-E RANGE MEAL (AN) (C100) (LL) MEDICATED, 4685-N LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304073985 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary CALF CREEP FEED (B45) (LL) MEDICATED, 4078-B LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304073848 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), NutreBeef (R), CATTLE GROWER/FINISHER TEXTURED (LL), 93913 LL, NET WEIGHT ON BAG OR BULK, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304271084 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary COMMODITY 12 (LL), 151013 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304273286 4K1213 - 4K1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary EQUINE ONE (LL), 9510 LL, NET WEIGHT ON BAG OR BULK, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304209810 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary WENDLAND'S One 'N Only FREE CHOICE COMPLETE HORSE FEED, 151165, Net Weight 50 LBS. (22.68 Kgs.), Manufactured for WENDLAND'S FARM PRODUCTS, A DIVISION OF JUPE FOODS, INC. TEMPLE, TEXAS 76504 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Nutrena (R), EMPOWER (R) BOOST, 7613 LL, NET WEIGHT ON BAG OR BULK, and 1316-BK LL, (BULK), NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304261406 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary RURAL KING 32% FARM POND FLOATING CATFISH FOOD (LL), 960-R4 LL, NET WEIGHT 40 LB (18.14 kg), MANUFACTURED FOR: RURAL KING, MATTOON, IL 61938, MANUFACTURED BY: CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304253240 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Sportsman's Choice, CATFISH FEED (LL), 45050 LL, NET WEIGHT 50 LB (22.67 kg) BAG, CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 72230425932 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary WENDLAND'S 32% FLOATING FISH FEED (LL), 151194 LL, Net Weight 50 LBS. (22.68 Kg) BAG, MANUFACTURED FOR WENDLAND'S FARM PRODUCTS, A DIV. OF JUPE FOODS, INC., TEMPLE, TEXAS 76504 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class III Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary ACCO FEEDS (R) Showmaster (R) POWER PHAT (TM) (LL), 10739-25 LL, NET WEIGHT 25 LB (11.33 kg), ACCO FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304239107 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class II Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary WENDLAND'S DEER-LICIOUS NUGGETS (LL), 151195 LL, NET WEIGHT 40 LB (18.14kg), MANUFACTURED FOR WENDLAND'S FARM PRODUCTS, A DIV. OF JUPE FOODS, INC., TEMPLE, TEXAS 76504 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Veterinary Sportsman's Choice, RECORD RACK, GOLDEN DEER NUGGET (TM) (LL), 45011 LL, NET WEIGHT 40 LB (18.14 kg), CARGILL ANIMAL NUTRITION, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC 722304504402 Lot Codes: 4K0335 - 0K0365, LL0335 - LL0365, 4K1001 - 4K1335, and LL1001 - LL1335 Class I Animal feed may have elevated levels of Aflatoxin Cargill Inc Animal Nutrition Division
Drugs Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot HB06311 Class II Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. Lloyd Inc
Drugs Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot 1087589 Class II Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. Lloyd Inc
Drugs Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601 LOT NO.1092045 Class II Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. Lloyd Inc
Drugs Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601. HD17811 Class II Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. Lloyd Inc
Veterinary Virbac IVERHART MAX (ivermectin/pyrantel pamoate/praziquantel), Chewable Tablets for Dogs 50.1 to 100 lbs., packaged in 6-tablet boxes, 10 boxes/display case, each chewable tablet contains 272 mcg ivermectin, 228 mg pyrantel as pamoate salt and 228 mg praziquantel, RX, NADA 141-257. Manufactured by Virbac AH, Inc., Fort Worth, TX. Lot #110482, Exp. date 11:2013 Class III Stability failure (low) at 9-month test interval Virbac Inc
Food Jugos Naturales del Pepino, Jugo de China Natural (Natural Orange Juice), 1 Gal (128 oz), Este producto no está pasteurizado (This product is not pasteurized), Carr 466 Km 4.7 Bo. Robles, San SEbastian, PR 00685 Exp. date 062512 Class II Product, subject to Juice HACCP regulation, manufactured without a HACCP Plan. Jugos Naturales del Pepino, Inc.
Drugs Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78 Lot # 34000741A; Expiration date: 7/2013 Class II Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. Teva Pharmaceuticals USA, Inc.
Devices Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. All products Class II Brush battery cap was forcibly blown off at the end of the brush handle. Colgate Palmolive Company
Devices Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. All products Class II Brush battery cap was forcibly blown off at the end of the brush handle. Colgate Palmolive Company
Devices Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. All products Class II Brush battery cap was forcibly blown off at the end of the brush handle. Colgate Palmolive Company
Devices Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. All products Class II Brush battery cap was forcibly blown off at the end of the brush handle. Colgate Palmolive Company
Devices Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. All products Class II Brush battery cap was forcibly blown off at the end of the brush handle. Colgate Palmolive Company
Devices GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone Model FL20E: Serial,Number,Listing,for,Model,FL20E QG06844, QG06842, G08119, G08118, G08117, G08116, G08115, G08114, G08113, G08112, G08111, G08110, G08109, G08108, G08107, G08106, G08105, G08104, G08103, G08102, G08101, G08100, G08099, G08098, G08097, G08096, G08095, G08094, G08093, G08092, G08091, G08090, G08089, G08088, G08087, G08086, G08085, G08084, G08083, G08082, G08081, G08080, G08079, G08078, G08077, G08076, G08075,  ...
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Class II An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inaccurate scale reading. Bed exit faults are manifested as the inability to arm the bed exit and the bed exit system alarming without an exit. No adverse events have occurred. Stryker Medical Division of Stryker Corporation
Devices Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone Model FL28C: Serial Number R25210, R21286, R20899, R16969, R16968, R15495, R15494, R15493, R15492, R15491, R15490, R15489, R15488, R15487, R15486, R15485, R15484, R15483, R15482, R15481, R15480, R15479, R15478, R15447, R15446, R15445, R15444, R15443, R15442, R15441, R15440, R15439, R15438, R15437, R15436, R15435, R15434, R15433, R15432, R15431, R15430, R15429, R15428, R15427, R15426, R15425,  ...
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Class II An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inaccurate scale reading. Bed exit faults are manifested as the inability to arm the bed exit and the bed exit system alarming without an exit. No adverse events have occurred. Stryker Medical Division of Stryker Corporation
Devices Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone Model FL14E: Serial Number QB22371, QB22370, QB22369, QB22368, QB22367, QB21200, QB18330, QB17733, B22524, B22523, B22522, B22521, B22506, B22505, B22504, B22503, B22502, B22501, B22500, B22446, B22445, B22444, B22443, B22442, B22441, B22440, B22439, B22438, B22437, B22436, B22435, B22427, B22426, B22425, B22424, B22423, B22422, B22421, B22420, B22419, B22373, B22372, B22308, B22307, B22306, B22305,  ...
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Class II An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inaccurate scale reading. Bed exit faults are manifested as the inability to arm the bed exit and the bed exit system alarming without an exit. No adverse events have occurred. Stryker Medical Division of Stryker Corporation
Devices Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone Model FL25E: QK02276, QK02274, QK01602, KK01602, K03922, K03921, K03920, K03919, K03918, K03917, K03916, K03915, K03914, K03913, K03912, K03911, K03910, K03909, K03908, K03907, K03906, K03905, K03904, K03903, K03902, K03901, K03900, K03899, K03898, K03897, K03896, K03895, K03894, K03893, K03892, K03891, K03890, K03889, K03888, K03887, K03886, K03885, K03884, K03883, K03882, K03881, K03880, K03879,  ...
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Class II An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inaccurate scale reading. Bed exit faults are manifested as the inability to arm the bed exit and the bed exit system alarming without an exit. No adverse events have occurred. Stryker Medical Division of Stryker Corporation
Devices Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone Model FL28EX, Serial Numbers: QR09842, QM10376, QM10375, QM10374, QM10373, QM10372, QM10371, QM10370, QM10369, QM10368, QM10367, QM10366, QM10365, QM10364, QM10363, QM10362, QM10361, QM10360, QM10359, QM10358, QM10357, QM10356, QM09893, QM09883, QM09829, QM09827, QM09805, QM09804, QM09803, QM09802, QM09801, QM09800, QM09799, QM09798, QM09797, QM09796, QM09795, QM09794, QM09793, QM09444, QM08965, QM08916, QM08832, QM08230, QM08211, QM08210,  ...
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Class II An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inaccurate scale reading. Bed exit faults are manifested as the inability to arm the bed exit and the bed exit system alarming without an exit. No adverse events have occurred. Stryker Medical Division of Stryker Corporation
Devices Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 203861: 0548731, 0552411, 0556018, 0558941, 0563005, 0565138, 0565841, 0569745, 0570058, 0571163, 0571584, 0573043, 0573288, 0575518, 0580832, 0583446,0585251, 0586160, 0590448, 0591942, 0596210, 0600490, 0607020, 0618429, 0619201, 0630155, 0634777, 0640509, 0649185, 0652212, 0655898, 0661142, and 0668560. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 203887 and lot numbers: 0551678, 0557083, 0561754, 0562984, 0568008, 0572137, 0575072, 0580833, 0583190,0586161,0591033,0596204, 0605323, 0612587, 0615536, 0619196, 0622171,0627245,0631928,0632342, 0639031,0641468,0648454,0650700, 0652249,0653439,0660677, and 593715C. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 203895 and lot numbers: 0551294, 0555085, 0557607, 0560171, 0563852, 0568020, 0572133, 0579089, 0586166, 0592735, 0598461, 0603720, 0611573, 0616893, 0619181, 0625003, 0633298, 0637811, 0640423, 0645344, 0649186, 0652248, 0655897, 0662813, and 621706C. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 203879 and lot numbers: 0558280, 0574328, 0590421, 0607092, 0613016, 0627693, 0641300, 0653436, 0655320, and 0666687. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 66015 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 71415-03 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 71415-04 and lot number: NN07 Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 71619 and lot number: ND14 and NE11. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 71936-01 and lot number: MH06, ML20, MN15, NG20, and NG20A. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 71936-02 and lot number: PC06 Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 73395 and lot number: MK30 and MK30T Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 74301 and lot number: PD19 Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 74302 and lot number: PD19 Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80001-01 and lot number: MG21, MM04, NA24, ND21, NK01, NM31, and PA30. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80001-02 and lot number: NP20 and PA16. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80002-03 and lot number: MH12, MK30, MP06, NE18, NM31, and NN28. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80003-02 and lot number: MH12, MK30, MP06, NA31, NE18, NF23, NM31, NN28, NP19, and PD05. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80004-02 and lot number: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80004-03 and lot number: NP20 Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Catalog number: 80004-03 and lot number: MG14, MK16, MN15, NC07, NE18, NK01, NM31, PA30, and PD05. Class II During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined and any unit manufactured within the last three years could potentially be affected. It is possible that the substance could be dislodged from the inside tip of the Sarns antegrade cannula and subsequently introduced into the patient bloodstream. Particulate matter injected into the aortic root has the potential for travel to the coronary arteries or elsewhere in the vasculature system. Terumo Cardiovascular Systems Corporation
Devices BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies Device catalog No. OVIO03 (not lot specific) Class II Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened. Siemens Healthcare Diagnostics, Inc.
Drugs Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013 Class II Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications. Teva Pharmaceuticals USA, Inc.
Food Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimmon Hill Lane, Lame, MO 65681. Lot 10131 Class II The product did not meet the temperature requirements during the manufacturing process. Persimmon Hill Farm Gourmet Foods
Food Organic Paprika packaged under the following labels: (1) Archer Farms organic Paprika, packaged in 1.0-oz rectangle glass bottles, packed in cases-9 glass bottles/case, Distributed by: Target Corporation, Minneapolis, MN 55483; and (2) O Organic organic Paprika, packaged in 1.6-oz glass bottles, packed in cases- 48 glass bottles/case, Distributed by: Lucerne Foods, Inc, Pleasanton, CA 94566. Archer Farms lot # 2761107A; O Organics lot # 2591103A Class II Organic Paprika contains unapproved colors. Brinkhoff & Monoson Inc
Food Organic 100% Pomegranate Juice packed in glass bottles Smart Juice Organic Pomegranate 100% Juice 33.8 FL. Oz. 100% Juice Distributed by: Smart Juices LLC, Bethlehem, PA 18018 BBE: 09.09.2014 ORGANIC N49 BBE: 09.09.2014 ORGANIC N49 Class II Pomegranate juice contains levels of lead above allowable limits. Smart Juice LLC
Biologics Red Blood Cells Leukocytes Reduced W044611436284; Class II Blood products, collected from a donor who was previously deferred, were distributed. Gulf Coast Regional Blood Center
Biologics Blood and Blood Products for Reprocessing W044611436284; Class III Blood products, collected from a donor who was previously deferred, were distributed. Gulf Coast Regional Blood Center
Biologics Platelets W044611436284; Class III Blood products, collected from a donor who was previously deferred, were distributed. Gulf Coast Regional Blood Center
Biologics Source Plasma 0630042647; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Biomat USA, Inc.
Devices Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma. B12 Flex(R) reagent cartridge (K6442) - IFBA Interference All lots -- 07304AA, Exp 5/28/08; 08021AB, Exp 1/20/09; 08042AC, Exp 2/10/09; 08071AA, Exp 3/11/09; 08114AC, Exp 4/23/09; 09019AC, Exp 1/19/10; 09019AB, Exp 1/19/10; 09040AA, Exp 2/10/10; 09068AA, Exp 3/9/10; 09085AB, Exp 3/26/10; 09110AE, Exp 4/20/10; 09140AD, Exp 5/19/10; 09180AC, Exp 6/29/10;  ...
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Class II Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista System. This issue affects all lots of B12 Flex reagent cartridges on the Dimension Vista System. Siemens Healthcare Diagnostics, Inc.
Food Salted/marinated Pollock roe packaged in white plastic trays with either a clear or opaque plastic lid. Product is packaged in 1.0 lb., 2.2 lb., and 5 lb. sizes and is labeled in part: "Marinated Pollock Roe***Weight: 5.0lb***Production Date: March 2012 Packed by: Young Ocean Inc. 20233 80th Ave. S., Kent, WA 98032". There are 2 labels for the 1.0 lb. size which read in part: 1. "Salted Pollock Roe***Spicy:***Colored***Net Weight: 1.0LB (435g) Ingredients: Pollock Roe, Salt, MSG, Sorbitol, Sake, Mirin Best Before: April 2015***Young Ocean Inc.***". 2. "Salted Pollock Roe***Net Weight: 1.0 LB (435g) Ingredients: Pollock Roe, Salt, MSG, Sorbitol, Sake, Mirin, NaNo2, Artificial Color Additives (R-40, Y-5, R-5) Best Before: April 2015***Young Ocean Inc.***". "Production Date: March 2012" and/or "Best Before: April 2015" Class II Use of Red #5 in Salted Pollock Roe and undeclared Red #5, Yellow #5 and Red #40 in Salted Pollock Roe. Young Ocean, Inc
Devices Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397 Class II Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products Hartmann USA, Inc
Devices Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394 Class II Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products Hartmann USA, Inc
Biologics Red Blood Cells Leukocytes Reduced W115112179769N; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W115112148563F; Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. LifeSouth Community Blood Centers Inc
Biologics Fresh Frozen Plasma W115112148563F; Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. LifeSouth Community Blood Centers Inc
Biologics Red Blood Cells Leukocytes Reduced W043210016443; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043210016443; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Devices Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation. Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF1024535, ZF1025078, ZF1036034, ZF1036293, ZF1047553, ZF1068055, ZF1079398, ZF1080286, ZF1091018, ZF1102643, ZF1103235, ZF1113530, ZF1114129, ZF1114632, and ZF2016475. PN AD-24703-OB -- lots ZF1013508, ZF1024536, ZF1025079, ZF1036035, ZF1036449, ZF1057072, ZF1068314, ZF1079528, ZF1080288, ZF1080633, ZF1091019, ZF1092076, ZF1102574, ZF1124769, ZF1124963, ZF1125081, and  ...
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Class I Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status. Arrow International Inc
Devices Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. Catalog number 47-4307-031-00; lot 62071190 Class II Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. Zimmer, Inc.
Devices Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe. Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500). Serial numbers: 12B037204, 12B037214, 12B037224, 12B037234, 12B040594, 12B040604, 12B040614, 12B040624, 12B040634, 12B040644, 12B040654, 12B040664, 12B040684, 12B041374, 12B046934, 12B046964, 12B046974, 12B046994, 12B047004, 12B047014, 12B047024, 12B047034, 12B047054, 12B047064, 12B047074, 12B047084, 12B047094, 12B049204, 12B049234, 12B049244, 12B055744, 12B055754, 12B055764, 12B055774. Class II Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control. Stryker Endoscopy
Cosmetics SCHULTZ SUPPLY brand Pearlized Pink Hand Soap, Kutol Catalog #5909SSC. The product is packed in one (1) gallon plastic jugs/bottles Net Contents: 3,785 L, and is distributed in cases which contain four (4) gallons per case, The bottle label reads: Pearlized Pink Hand Soap *Cleans hands thoroughly *Great soft scent and feel *Perfect for wherever a quality hand soap is needed' ***Schultz Supply 3215 S. 59th Ave./Cicero, IL 60604 (708) 652-2020/www.schultzsupply.com The recalled product is identified with the following Lot Numbers: 090317001  ...
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Class III The recalling firm produced and distributed a cosmetic pink hand soap which contains the unapproved ingredient Red Dye 15 (also known as Basic Violet 10) This dye is not approved for use in food, drugs or cosmetics. Kutol Products Co Inc
Devices PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample Cat No. 1720; and Lot number F103 Class II During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay. Polymer Technology Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced W120612088897 Class II Blood products, possibly contaminated with air, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120612004634 Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Michigan Blood
Food Broaster Fish Coating, 96627, Ingredients: Corn Meal, Wheat Flour, Corn Crumbs, Salt, Spices, Paprika, Citric Acid, Onion, Sugar, Garlic, Celery Seed, Modified Con Starch, Lemon Oil, Natural and Artifical Flavors, Silicon Dioxide (Anti-Caking Agent) and FD&C yellow #5., Net Weight 20 pounds, Manufactured By The Broaster Company, Beloit, Wisconsin 53511. 12-108-296 12-073-194 12-004-012 Class II The Broaster Company, LLC is recalling three lots of Broaster Fish Coating 96627 because they contain an undeclared color additive, Yellow Dye No. 6. The Broaster Company, LLC
Biologics Source Plasma 2160059500; 2160066675; 2160070894; 2160078339; Class III Source Plasma, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160078618 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074117; 2160078385; 2160079350; 2160059861; 2160061927; 2160063919; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063846; 2160067368; 2160071022; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed Plasmacare Inc
Biologics Source Plasma 2160063923; 2160065015 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063950; 2160064172; 2160065690; 2160065887; 2160067361; 2160068449 Class III Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W333612052335 Class II Blood product, mislabeled as to antigen phenotype, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572; W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing V89413 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043212037217-A; W043212037217-B Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043211081138 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211081138 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W041912010004J Class II Blood product, which did not meet acceptable product specifications, was distributed. Blood Systems, Inc.
Biologics Platelets Leukocytes Reduced W115911013637 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115911274353; W115911045584 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Central California Blood Center
Drugs Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01 Lot number: 2021956, Exp; 01/2013 Class II Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point. Shionogi Inc.
Veterinary OPHTHALMIC PRODUCTS: (No labeling available) CHLORAMPHENICOL 0.5% OPHTHALMIC 10 ML. CIPROFLOXACIN HCL 0.4% OPHTHALMIC 10 ML. CYCLOSPORINE (A) (CANNOLA OIL) 1% OPHTHALMIC 10 ML, 15 ML. CYCLOSPORINE (A) (CORN OIL) 1% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 40 ML, 60 ML. CYCLOSPORINE (A) /TACROLIMUS OIL SOLUTION 1%/0.01% OPHTHALMIC 10 ML. CYCLOSPORINE (A) /TACROLIMUS OIL SOLUTION 1%/0.02% OPHTHALMIC 15 ML. CYCLOSPORINE (A) /TACROLIMUS OIL SOLUTION 2%/0.01% OPHTHALMIC 15 ML. CYCLOSPORINE (A) /TACROLIMUS OIL SOLUTION 2%/0.02% OPHTHALMIC 10 ML, 15 ML. CYCLOSPORINE (A) AQUEOUS 2% OPHTHALMIC 15 ML. CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML. CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML. CYCLOSPORINE (A) OIL SOLUTION 0.05% OPHTHALMIC 15 ML. CYCLOSPORINE (A) OIL SOLUTION 0.2% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 60 ML. CYCLOSPORINE (A) OIL SOLUTION 0.5% OPHTHALMIC 10 ML, 15 ML. CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 40 ML, 45 ML, 50 ML, 60 ML, 100 ML, 105 ML, 120 ML. CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 5 ML, 7.5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 40 ML, 60 ML, 80 ML, 90 ML, 100 ML . CYCLOSPORINE (A) OLIVE OIL SOLUTION 1% OPHTHALMIC 15 ML. CYCLOSPORINE (A) OLIVE OIL SOLUTION 2% OPHTHALMIC 5 ML, 10 ML. DESMOPRESSIN ACETATE, OPHTHALMIC 0.1MG/ML (10MCG/0.1ML) SOLUTION 5 ML, 7 ML, 10 ML,15 ML. DICLOFENAC SODIUM DROP ** 0.1% OPHTHALMIC 5 ML. DICLOFENAC SODIUM SOLUTION 0.1% OPHTHALMIC 60 ML. DICLOFENAC SODIUM/ DMSO SOLUTION 1%/1% OPHTHALMIC 30 ML. DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML. FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 15 ML, 30 ML. FLURBIPROFEN SOLUTION 50ML 0.03% OPHTHALMIC 50 ML. FLURBIPROFEN SOLUTION** 0.03% OPHTHALMIC 2.5 ML. GENTAMICIN/ACETYLCYSTEINE/PILOCARPINE 2.5MG/60MG/6MG/ML OPHTHALMIC 20 ML, 30 ML, 40 ML, 60 ML. IDOXURIDINE SOLUTION 0.5% OPHTHALMIC 5 ML, 15 ML, 45 ML. IDOXURIDINE SOLUTION 0.1% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 45 ML. ITRACONAZOLE SUSPENSION 1% OPHTHALMIC 30 ML. ITRACONAZOLE/DMSO SOLUTION 1%/15% OPHTHALMIC 15 ML. ITRACONAZOLE/DMSO SOLUTION 1%/30% OPHTHALMIC 15 ML, 30 ML. ITRACONAZOLE/DMSO/GENT SOLUTION 1%/30%/0.5MG/ML OPHTHALMIC 45 ML. KCS OPHTHALMIC 0.3%/6.67%/0.67% SOLUTION 75 ML. MICONAZOLE SOLUTION 1% OPHTHALMIC 15 ML, 20 ML, 30 ML, 40 ML, 60 ML, 90 ML, 100 ML, 180 ML. MICONAZOLE SOLUTION 2% OPHTHALMIC 5 ML, 10 ML, 15 ML, 30 ML. MICONAZOLE/DMSO, SOLUTION 2%/30% OPHTHALMIC 30 ML. MICONAZOLE/TOBRAMYCIN SOLUTION 1%/0.3% OPHTHALMIC 30 ML. MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 7 ML. NALBUPHINE HCL 1.2% OPHTHALMIC 12 ML. NATAMYCIN SUSPENSION 3.3% OPHTHALMIC 5 ML, 10 ML, 15 ML. NATAMYCIN SUSPENSION, (STERILE VIAL-LAVAGE) 5% OPHTHALMIC 15 ML. NATAMYCIN SUSPENSION, 15ML*** 5% OPHTHALMIC 15 ML, 30 ML, 45 ML, 90 ML. NEOMYCIN/BACITRACIN/POLYMYXIN-B/DEXAMETHASONE, OPHTHALMIC 5MG/400IU/10000U/1% OI 50 GM, 60 GM. NEOMYCIN/BACITRACIN/POLYMYXIN-B/HYDROCORT OPHTHALMIC 3.5MG/400U/10,000U/GM/1% OI 4 GM. NEOMYCIN/BACITRACIN/POLYMYXIN-B/HYDROCORT OPHTHALMIC 7.5MG/600U/10,000U/GM/1% OI 4 MG, 8MG, 16 GM, 24 GM, 48 GM. NEOMYCIN/POLYMYXIN/BACIT SOLUTION 3.5MG/10,000U/500U/ML OPHTHALMIC 15 ML, 30 ML. POLYMYXIN B SULFATE 10000 UNITS/ML OPHTHALMIC 10 ML. TACROLIMUS AQUEOUS OPHTHALMIC 0.01% SUSPENSION 10 ML, 15 ML. TACROLIMUS AQUEOUS OPHTHALMIC 0.02% SUSPENSION 10 ML, 15 ML. TACROLIMUS AQUEOUS OPHTHALMIC 0.03% SUSPENSION 15 ML. TACROLIMUS OIL SOLUTION 0.01% OPHTHALMIC 10 ML. TACROLIMUS OIL SOLUTION 0.02% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 40 ML, 60 ML. TACROLIMUS OIL SOLUTION 0.03% OPHTHALMIC 5 ML, 10 ML, 15 ML, 20 ML, 30 ML. TACROLIMUS OIL SOLUTION, ALMOND OIL 0.03% OPHTHALMIC 10 ML. TACROLIMUS OIL SOLUTION, CORN OIL 0.02% OPHTHALMIC 10 ML, 15 ML. TACROLIMUS OIL SOLUTION, CORN OIL 0.03% OPHTHALMIC 5 ML, 10 ML, 15 ML. TIMOLOL MALEATE SOLUTION, 15ML** 0.5% OPHTHALMIC 15 ML. VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 10 ML, 15 ML, 20 ML. RX #'s: 0387911 0381431 0389075 0389075 0389075 0389075 0401548 0403475 0408637 0394895 0394895 0388625 0397986 0360644 0403535 0401573 0387993 0387993 0387993 0387993 0387993 0365237 0408756 0361363 0394368 0394368 0394368 0373042 0373042 0356454 0404511 0404511 0408900 0394807 0403180 0387393 0387393 0377302 0377302 0377302 0365012 0405621 0394283 0393012 0393012 0362963 0362917 0405988  ...
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Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary OPHTHALMIC OINTMENT PRODUCTS: (No labeling available) ACYCLOVIR OPHTHALMIC 3% OINTMENT 6 ML. ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM. CHLORAMPHENICOL OINTMENT 1% OPHTHALMIC 5 GM, 8 GM, 12 GM, 20 GM, 24 GM, 30 GM, 40 GM, 120 GM, 10ML AND 30 ML. CHLORAMPHENICOL/MICONAZOLE/DMSO OINTMENT 2%/2%/1% OPHTHALMIC 30 GM. CIPROFLOXACIN OPHTHALMIC 0.5% OINTMENT 24 GM. CYCLOSPORINE OINTMENT 0.1% OPHTHALMIC 4GM, 5 GM, 10 GM, 15 GM, 20 GM, 30 GM, 90 GM, AND 10 ML. DEXAMETHASONE OINTMENT 0.1% OPHTHALMIC 3.5 GM AND 10 GM. DICLOFENAC SODIUM OINTMENT 0.1% OPHTHALMIC 5 GM, 7GM, 8 GM, 10 GM, 10.5 GM, 14 GM, 15 GM, 16 GM, 30 GM, 32 GM, 50 GM. DMSO OPHTHALMIC 2% OINTMENT 5 GM. EDTA OPHTHALMIC 1% OINTMENT 5 GM AND 15 GM. FLUOROURACIL (5-FU) OINTMENT 0.5% OPHTHALMIC 60 GM FLUOROURACIL (5-FU) OINTMENT 1% OPHTHALMIC 4 GM, 5 GM, 10 GM, 15, GM, 20 GM, 30 GM, 36 GM, 40 GM. FLUOROURACIL (5-FU) OINTMENT 2% OPHTHALMIC 10 GM AND 15 GM. FLUOROURACIL (5-FU) OINTMENT 3% OPHTHALMIC 5 GM, 20 GM, AND 30 GM. FLUOROURACIL (5-FU) OINTMENT-VET ONLY 5% OPHTHALMIC 15 GM, AND 30 GM. FLURBIPROFEN PF (V/V) OINTMENT 0.03% OPHTHALMIC 15 GM AND 20 GM. GENTAMICIN OINTMENT 0.5% OPHTHALMIC 25 GM. IDOXURIDINE OINTMENT 0.1% OPHTHALMIC 15 GM. INTERFERON ALFA-2B, OINTMENT 30 IU/GM OPHTHALMIC 5 GM. ITRACONAZOLE OINTMENT 1% OPHTHALMIC 4 ML, 30 ML, 4GM, 30 GM. ITRACONAZOLE/DMSO OINTMENT 1%/15% OPHTHALMIC 4 GM, 8 GM, 10 GM, AND 24 GM. ITRACONAZOLE/DMSO OINTMENT 1%/30% OPHTHALMIC 10GM, 16 GM, AND 40 GM. ITRACONAZOLE/DMSO/NEOMYCIN OINTMENT 0.5%/10%/2% OPHTHALMIC 10 GM. ITRACONAZOLE/DMSO/OFLOXACIN OINTMENT 0.5%/10%/0.03% OPHTHALMIC 30 GM. IVERMECTIN OINTMENT 1% OPHTHALMIC 3MG, 4 GM, 5 GM, 10 GM, 15 GM, 45 GM. MICONAZOLE OINTMENT 1% OPHTHALMIC 4 GMS, 5 GMS, 8 GMS, 10 GMS, 12 GMS, 16 GMS, 20 GMS, 24 GMS, 32 GMS, 52.5 GMS 70 GMS, 87.5 GMS, 105 GMS, 122.5 GMS, 140 GMS. MICONAZOLE OINTMENT 2% OPHTHALMIC 4 GM, 8 GM, 30 GM, 40 GM, 48 GM, 80 GM. MICONAZOLE/DMSO OINTMENT 1%/5% OPHTHALMIC 20 GM. MICONAZOLE/DMSO OINTMENT 2%/5% OPHTHALMIC 3.5 GMS. MITOMYCIN OPHTHALMIC OINTMENT 0.04% (400MCG/ML) OPHTHALMIC 5 GM. NEOMYCIN/BACITRACIN/POLYMYXIN-B OPHTHALMIC 3.5MG/400U/15,000U/GM OINTMENT 4 GM and 24 GM. NEOMYCIN/BACITRACIN/POLYMYXIN-B OPHTHALMIC 7.5MG/600U/10000U/GM OINTMENT 4 GM, 8 GM, 12 GM, 16 GM, 20 GM, 24 GM, 30 GM, 32 GM, 40 GM, 48 GM, 50 GM, 52 GM, 92 GM, 96 GM, 144 GM. NYSTATIN OINTMENT 1% OPHTHALMIC 3.5 GM. OPTIMMUNE**OPHTHALMIC 0.2% OINTMENT 3.5 GMS. OXYTETRACYCLINE HCL/POLYMYXIN B (PF) OPHTHALMIC 0.5%/10,000 IU/GM OINTMENT 5 GM, 8 GM, 12 GM, 15 GM, 20 GM, 24 GM, 30 GM, 32 GM, 50 GM. OXYTETRACYCLINE OINTMENT 1% OPHTHALMIC 3.5 GM, 4 GM, 8 GM, 10.5 GM, 22 GM. PREDNISOLONE ACETATE OINTMENT 1% OPHTHALMIC 15 GRAM. TACROLIMUS OINTMENT 0.02% OPHTHALMIC 4 GM, 5 GM, 8 GM, 10 GM, 15 GM. TACROLIMUS OINTMENT 0.03% OPHTHALMIC 3 GM, 4 GM, 5 GM, 8 GM, 15 GM, 16 GM. TACROLIMUS OINTMENT 0.05% OPHTHALMIC 8 GM. TACROLIMUS OINTMENT 0.1% OPHTHALMIC 5 GMS. TACROLIMUS OINTMENT 0.3% OPHTHALMIC 5 GMS. VORICONAZOLE OPHTHALMIC 1% (10MG/ML) OINTMENT 3.5 GM, 5 GM, 15 GM. REX #'s: 0399876 0406303 0369646 0369646 0369646 0369646 0374463 0374463 0374463 0374463 0374463 0389926 0389926 0389926 0400266 0370082 0370082 0370082 0370082 0389688 0389688 0388384 0388384 0388384 0404678 0394310 0387718 0387718 0391476 0402038 0361990 0377727 0377727 0397981 0356342 0393409 0381097 0403636 0368797 0368797 0410154 0382649 0382649 0396930 0386183 0396066 0397879 0397879  ...
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Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary TOPICAL OPHTHALMIC PRODUCTS / ARTIFICAL TEARS: (No labeling available) ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS - 2.5% 15 ML, 5%, 15ML, AND 10% IN 5ML, SOLUTION. CEFAZOLIN OPHTHALMIC IN ARTIFICIAL TEARS 66MG/ML OPHTHALMIC 15 ML. CEFAZOLIN SOLUTION IN ARTIFICIAL TEARS 55MG/ML OPHTHALMIC 5 ML,10 ML, 15ML AND 20ML. CEFTAZIDIME OPHTHALMIC IN ARTIFICIAL TEARS 50MG/ML (5%) OPHTHALMIC 5 ML. DEMECARIUM BROMIDE OPHTHALMIC IN ARTIFICIAL TEARS 0.25% OPHTHALMIC 10ML AND 15 ML. EDTA CALCIUM DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.5% OPHTHALMIC 15 ML. EDTA DISODIUM IN NATURAL TEARS 1% OPHTHALMIC 10ML AND 15 ML. FLUCONAZOLE SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML AND 30 ML. FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 2% OPHTHALMIC 10 ML AND 15 ML. GENTAMICIN/ACETYLCYSTEINE/ATROPINE IN ARTIFICIAL TEARS 0.25%/2.5%/0.25% OPHTHALM 30 ML. IVERMECTIN/DEXAMETHASONE/DMSO IN ARTIFICIAL TEARS 1%/1%/15% OPHTHALMIC 15 ML. MICONAZOLE IN ARTIFICIAL TEARS SOLUTION 1% OPHTHALMIC 30 ML. REX #'S: 0392042 0392042 0396445 0405722 0404274 0388995 0389316 0389316 0389316 0389316 0389316 0391240 0393461 0388057 0388057 0388057 0388057 0388057 0388057 0388057 0381667 0381667 0381667 0381667 0368803 0400485 0387763 0387763 0387763 0387763 0401511 0401511 0398728 0398728 0388724 0388724 0404803 0389669 0393532 0380503 0386380 0406901 0395425 0395425 0402583 0402583 0404765  ...
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Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary TOPICAL IRRIGATION: (No labeling available). CLOTRIMAZOLE UTERINE FLUSH, STERILE 500MG/60ML (8.33MG/ML) SOLUTION 300 ML, 500 ML. CLOTRIMAZOLE UTERINE FLUSH, STERILE 500MG/20ML (25MG/ML) SOLUTION 140 ML, 168 ML. REX #'S: 0357765 0357765 0357765 0401780 0400714 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary TOPICAL: (No labeling available). AMIKACIN SULFATE, OTIC 2% SOLUTION 90 ML. AMIKACIN / TOBRAMYCIN OTIC 250MG / 10MG / ML DROP 30 ML. REX #'S: 0390908 0406310 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary ORAL: (No labeling available). CYPROHEPTADINE 100MG/ML SUSPENSION 60 ML, 90 ML, 100 ML 180 ML, 240 ML, 360 ML, 480 ML. CIMETIDINE 1.5GM/LEVEL SCOOP SCOOP 120 SCOOP. CYCLOSPORINE 15MG CAPSULE 60 CAPS. LACTULOSE, FLAVORED 10GM/15ML SYRUP 90 ML, 480 ML. REX #'S: 0403923 0408603 0387967 0387967 0387967 0387967 0387967 0387967 0387967 0387967 0387967 0387967 0410446 0406448 0394139 0404077 0354257 0354257 0354257 0397364 0397364 0397364 0397364 0397364 0397364 0397364 0397982 0397982 0397982 0408059 0363809 0400105 0408064 0410356 0383051 0383051 0383051 0383051 0383051 0383051 0383051 0369505 0365163 0365163 0365163 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary INJECTIBLE OPHTHALMIC (No labeling available). MITOMYCIN (OPHTHALMIC) SOLUTION, P.F. 5MG/ML INJECTABLE 4ML. REX #'S: 0398948 0398948 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary INJECTIBLE INTRAPERITONEAL: (No labeling available). CARBOXYMETHYLCELLULOSE (STERILE) 1% LIQUID 500 ML, 1000 ML, 2000 ML, 3000 ML. CARBOXYMETHYLCELLULOSE (STERILE) P&S 1% LIQUID 4000 ML. REX #'S: 0363639 0363639 0363639 0363639 0406218 0359530 0353354 0390217 0390217 0390217 0359380 0359380 0359380 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Veterinary DEVICE: (No labeling available). NEEDLE BD PRECISIONGLIDE** 18GX1" DEVICE (100 EA). INJECT- EASE*** DEVICE (1 EA). SYRINGE BD ULTRA-FINE II** 1ML (31G, 8MM) SYRINGE (20 SYRINGES). REX #'S: 0372951 0406960 0406808 0407647 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Biologics Source Plasma 2160057721; 2160058109; 2160060202; 2160073434; 2160078442; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Plasma Frozen within 24 hours (FP24) W037911146400 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing W037911171995 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 017FR95345 Class II Blood product, incorrectly labeled for Jk(a) red cell antigen, was distributed. American National Red Cross (The) - North Central Region
Devices OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. All Serial Numbers: P4-0004-L , P4-0005-L , P4-0006-R-RC1  ...
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Class II Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot. GE OEC Medical Systems, Inc
Devices MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. Lot 41928UQ11 {exp 2013-01 -31 ) Class II Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. Sekisui Diagnostics Llc
Food KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465 0502206602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, WHITE CHEDDAR SNACK SEASONING, CONTAINS MILK, Item Number 6000654.01, Net Wt 50 Lb (22.68 Kg) 0426260104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CREAMY PARMESAN SEASONING, CONTAINS MILK, Item Number 62310.01, Net Wt 50 Lb (22.68 Kg) 0426276401 -0426276404 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg) 0420276603 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEAS 0686, Contains Milk, Wheat, Net Wt 22.68 KG (50 lb), Item Number 10686.482 0412206603, 0503206601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE BLEND 77, 1150020, CONTAINS MILK AND SOY, Item # 17980.465, Net Wt 50 Lb (22.68 Kg) 0503206602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg) 0409258004 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, LASAGNA SKLT SEAS 10078, SE10078, CONTAINS MILK, Item # I10078.859, Net Wt 1600 Lb (725.69Kg) 0423205406 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK, Item # 717519.360, Net Wt 25 Lb (11.34Kg) 0402276402 0402276403 0402276404 0502276401 0502276402 0502276403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, THREE CHEESE MINI SHELLS 10109, CH10109 , CONTAINS MILK, CH718592 Item Number I10109.859, Net Wt 1600 Lb (725.69 Kg) 0417258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARMESAN ASIAGO TYPE SEASONING, CONTAINS MILK, Item # 718622.465, Net Wt 50 Lb (22.68 Kg) 0509257903 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR & SOUR CREAM 725775, CONTAINS MILK, Item # 725775.465, Net Wt 50 Lb (22.68 Kg) 0423223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465, Net Wt 50 Lb (22.68 Kg) 0430257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, THICK & CHEESY 0601, CH0601, CONTAINS MILK, Item Number 10601.859, Net Wt 1600 Lb (725.69 Kg) 0424205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465, Net Wt 50 Lb (22.68 Kg) 0511224104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607, Net Wt 1000 Lb (453.556 Kg) 0430258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, CREAMY PARMESAN SEAS S57CP, CONTAINS MILK, WHEAT, Item # 720104.465, Net Wt 50 Lb (22.68 Kg) 0410257905 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, CREAMY ITALIAN SEASONING S57CIT, CONTAINS MILK, Item # 720109.465, Net Wt 50 Lb (22.68 Kg) 0507257904 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK, Item # 720175.465, Net Wt 50 Lb (22.68 Kg) 0504257903 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT, Item # 720721.465, Net Wt 50 Lb (22.68 Kg) 0504257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM GARLIC 720850 R-SE-0152, CONTAINS MILK, Item # 720850.470, Net Wt 50 Lb (22.68 Kg) 0510276401, 0426276602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BACON 7 RANCH SEAS 720943 SE720943, CONTAINS MILK, SOY, WHEAT, Item # 720943.859, Net Wt 1600 Lb (725.69 Kg) 0416258002 0504258001 0507258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT, Item # I10079.859, Net Wt 1600 Lb (725.69 Kg) 0427205402 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEAS NAT, CONTAINS MILK, Item # 721108.465, Net Wt 50 Lb (22.68 Kg) 0504224104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, WHITE CHEDDAR SEAS 10230 SE10230, CONTAINS MILK, WHEAT, Item # I10230.859, Net Wt 1600 Lb (725.69Kg) 0426258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BUFFALO WING SEASONING , Item # I10256.465, Net Wt 50 Lb (22.68 Kg) 0507275301 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010, CONTAINS MILK, Item # I2868.465 , Net Wt 50 Lb (22.68 Kg) 0416205402 0417205401 0418205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 2237 code: d 1.29 edible, CONTAINS MILK, Item # I7097.465, Net Wt 50 Lb (22.68 Kg) 0418205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BUTTERMILK 987 CONTAINS MILK, Item # I2993.465, Net Wt 50 Lb (22.68 Kg) 0419205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, AU GRATIN SEAS 722912, CONTAINS MILK, WHEAT, Item # 722912.465, Net Wt 50 Lb (22.68 Kg) 0502206603 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ONION RING SEAS 18125 , CONTAINS MILK, Item # B18125.01, Net Wt 50 Lb (22.68 Kg) 0503224101 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT, Item # 722920.859, Net Wt 1600 Lb (725.69 Kg) 0427205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MAC 7 CHS SAUCE MIX 723357 CH723357, CONTAINS MILK, WHEAT, Item # 723357.859, Net Wt 1600 Lb (725.69 Kg) 0410258001 0416258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465, Net Wt 50 Lb (22.68 Kg) 0410257904 0508257901 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SALSA FRESCA 725058, Item # 725058.465, Net Wt 50 Lb (22.68 Kg) 0426276601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ITALIAN PASTA SALAD SEASONING, Item # 725445.859, Net Wt 1600 Lb (725.69 Kg) 0430258002 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, GOLDEN CHEDDAR CHEESE 716932 , R-SE-0132, CONTAINS MILK, Item # 716932.465, Net Wt 50 Lb (22.68Kg) KERRY, R-SE-0132TM, CONTAINS MILK, Item # 716932.TM, Net Wt 50 Lb (22.68Kg) 0510276403 0424276403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SEA SALT & VINEGAR 722536 R-SE-0155, , Item # 722536.440, Net Wt 40 Lb (18.14 Kg) KERRY, R-SE-0155TM, , Item # 722536.TM, Net Wt 40 Lb (18.14 Kg) 0420276401 0420276402 0420276403 0426275303 0426275302 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MOZZARELLA SESONING - NO PHSO, CONTAINS MILK, SOY, Item # I10187.465 , Net Wt 50 Lb (22.68Kg) 0502224108 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ROASTED GARLIC SEAS 10112, S37RG2 , CONTAINS MILK, SOY, Item # I10112.465, Net Wt 50 Lb (22.68Kg) 0410206604 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465, Net Wt 50 Lb (22.68Kg) 0417258002 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CRM & CHIVES 0989 S37SCC, CONTAINS MILK, , Item #I0989.465 , Net Wt 50 Lb (22.68Kg) 0510257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 , Net Wt 50 Lb (22.68Kg) 0430205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF PART # 117404 , CONTAINS MILK, Item #I10389.02 , Net Wt 50 Lb (22.68Kg) 0426223810 0420223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg) 0502224105 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF # 10987R, CONTAINS MILK, Item #B16903.01, Net Wt 50 Lb (22.68Kg) 0509224102 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR BEER TYPE 725554 , CONTAINS MILK, Item #725554.465, Net Wt 50 Lb (22.68Kg) 0423223802 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BATTER G3668, 1520374, CONTAINS MILK AND WHEAT, Item #G3668.MC1, Net Wt 50 Lb (22.68Kg) 0404216007 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, HOT CHEESE, SEAS, 04-20200, CONTAINS MILK , Item #I10185.465, Net Wt 50 Lb (22.68Kg) 0426258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEASONING 717379, 04-20200, CONTAINS MILK , SOY, Item # 717379.465, Net Wt 50 Lb (22.68Kg) 0425260117 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465, Net Wt 50 Lb (22.68Kg) 0426257901 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE SEASONING 15704, CONTAINS MILK, Item # B15704.01, Net Wt 50 Lb (22.68Kg) 0504224103 0504224102 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY, Item # I10103.465, Net Wt 50 Lb (22.68Kg) 0511223806 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK, Item # B16975.01, Net Wt 50 Lb (22.68Kg) 0430223802 0430223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEZ-TONE 6313, QO-05424 / QO-2200542400, CONTAINS MILK, Item # I6313.465, Net Wt 50 Lb (22.68Kg) 0410206601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 737, CODE:QO-05358, CONTAINS MILK, Item # I7126.465, Net Wt 50 Lb (22.68Kg) 0416205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK, WHEAT, Item # I8893.465, Net Wt 50 Lb (22.68Kg) 0419258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 1048, 95317, CONTAINS MILK, Item # I7067.465, Net Wt 50 Lb (22.68Kg) 0420205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARMESAN AND SUNDRIED TOMATO SEASONING, CONTAINS MILK, Item # B18122.01, Net Wt 50 Lb (22.68Kg) 0508276601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, HOT BUFFALO WINGS PRETZEL SEAS 173211, Item # B16413.01, Net Wt 44.5 Lb (20.18 kg) 0424223803 0424223804 0502223801 0502223802 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CREAM AND ONION 10286, CONTAINS MILK, Item # I10286.465, Net Wt 50 Lb (22.68 Kg) 0430275306 0430275307 0430275304 0430275305 0430275308 0430275301 0430275302 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM GARLIC SEAS 721221, CONTAINS MILK, Item # 721221.399 & 721221.398 , Net Wt 50 Lb (22.68 Kg) 0426223807 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food POLVORONES AMARILLO QTY: 100 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00161 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food CONCHA AMARILLA QTY: 90 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00158 and item number 120516 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food CONCHA CHOCOLATE QTY: 90 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00157 and item number 120516 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food CONCHA BLANCAS (VANILLA) QTY: 90 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00156 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food CONCHA ROSA QTY: 90 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00159 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food CUERNOS (CROISSANT) QTY: 90 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00149 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food MAGDALENA QTY: 54 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 8 95640 0019 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food TORTUGAS QTY: 60 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 8 95640 0053 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food EMPANADA PINA QTY: 100 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00134 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #6. Mexicantown Wholesale
Food TACOS DE PINA QTY: 120 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00144 and item number 120510 Distributed on 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared FD&C yellow #5. Mexicantown Wholesale
Food TACOS DE MANZANA QTY: 120 MEXICANTOWN BAKERY 313-894-2000 No Lot number; UPC: 0 95640 00143 and item number 120510 Delivery date 5/8/12 Class II The firm voluntarily recalled a total of 11 products: this product was recalled due to undeclared sulfites. Mexicantown Wholesale
Devices Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. D100622 Product Code Lot Number Expiration Date 199102S 237115 8/31/2012 199102S 238568 9/30/2012 199102S 238569 11/30/2012 199102S 237493 6/30/2012 2993 235489 11/30/2012 2993 238599 3/31/2013 2993SAMP 238369 3/31/2013 SAMP199102S 237493 6/30/2012 SAMP199102S 283569 11/30/2012 Class II They lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process. Ethicon, Inc.
Biologics Blood and Blood Products for Reprocessing 032LH13579; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 004F95004(Part A), 004F95004(Part B) Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Arc Blood Services, New England Region
Biologics Source Plasma 2160078204; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060670; 2160062540; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160070552; 2160070996; 2160077124; 2160067344; 2160067630; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160067973; 2160058853; 2160065674; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160084497; 2160082794; 2160084318; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160064096; 2160065128; 2160081218; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069673; 2160073440; 2160076055; 2160083364; 2160084379; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160074014; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160075485; 2160076387; 2160081186; 2160084466; Class III Source plasma, collected from a donor who did not have a complete medical history interview, were distributed. Plasmacare Inc
Biologics Source Plasma 2160075765; 2160077162; Class III Source plasma, collected from a donor who did not have a complete medical history interview, were distributed. Plasmacare Inc
Biologics Source Plasma 2160080204; Class III Source plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064997; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF1024535, ZF1025078, ZF1036034, ZF1036293, ZF1047553, ZF1068055, ZF1079398, ZF1080286, ZF1091018, ZF1102643, ZF1103235, ZF1113530, ZF1114129, ZF1114632, and ZF2016475. PN AD-24703-OB -- lots ZF1013508, ZF1024536, ZF1025079, ZF1036035, ZF1036449, ZF1057072, ZF1068314, ZF1079528, ZF1080288, ZF1080633, ZF1091019, ZF1092076, ZF1102574, ZF1124769, ZF1124963, ZF1125081, and  ...
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Class III Blood products, collected from donors who did not have a complete medical history interview, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063123; 2160068064; 2160073363; 2160078094; 2160079910; 2160081919; 2160060044; 2160061075; 2160062961; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160070883; 2160078590; Class III Blood poducts, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160079802; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058357; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160081504; 2160065658; 2160065917; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160061095; 2160063583; 2160064467; 2160065680; 2160084476; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063744; 2160058834; 2160061929; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed Plasmacare Inc
Biologics Source Plasma 2160057738; 2160058227; 2160061888; 2160064471; 2160067506; 2160070871; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069406; 2160069709; 2160078333; 2160067695; 2160068838; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160060123; 2160063542; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059695; 2160060073; 2160062921; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160078640; 2160079648; 2160079805; 2160081851; 2160082087; 2160083563; 2160084461; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Devices Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure. All lots Class I Risk of Alkalosis with acetate containing dialysis acid concentrates Fresenius Medical Care Holdings, Inc.
Devices Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure. All lots Class I Risk of Alkalosis with acetate containing dialysis acid concentrates Fresenius Medical Care Holdings, Inc.
Food Pasta Roni Parmesan Cheese Flavor angel hair pasta in a Parmesan sauce with other natural flavors; Net Wt. 5.1 oz. box/12 boxes/case; Distributed by Golden Grain Co., P.O. Box 049003, Chicago, IL 60604-9903; UPC 0 15300 44049 UPC 0 15300 44049, Best Before May 11 13, May 12 13, May 16 13 and May 18 13 Class II Two ingredients used in production of certain Pasta Roni products, were recalled by the supplier due to potential metal fragment contamination associated with the lactic acid used in production of the ingredient. Quaker Foods and Snacks North America
Drugs Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03 Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012. Class II Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life. Physicians Total Care, Inc.
Biologics Source Plasma 2160069905, 2160083354 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058243, 2160063981 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160078247, 2160083990 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066247 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059000 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160077828, 2160071343, 2160064283, 2160068504, 2160069139, 2160071196, 2160057761, 2160058659, 2160061228, 2160075702 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060621 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160063959, 2160065614, 2160073092, 2160076770 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058209 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160079868, 2160081248, 2160062606, 2160076085, 2160077166, 2160078324, 2160079630 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074939 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058986, 2160068943 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160062849, 2160063823 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160070151 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160070538, 2160081695 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059955, 2160060834, 2160078168 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160068068 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074502 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058206, 2160059880, 2160060132, 2160068885, 2160071167, 2160078042, 2160079918 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160079287 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066582, 2160070125, 2160070956, 2160076102, 2160078079 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074992 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059853 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066584 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160061702, 2160062904 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160079262 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160080569, 2160081277, 2160082082, 2160082411 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058172, 2160074955 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160078485 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160075475, 2160077618 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160074541 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060038 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160068832 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064365 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058960, 2160059474 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066799 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160064414, 2160065119 Class III Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065033; 2160073124; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160057641; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160076899; 2160066697; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058152; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160063963; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065695; 2160070466; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063219; 2160064334; 2160068159; 2160070142; 2160070831; 2160062376; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063017; 2160064287; 2160066646; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059358; 2160059785; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059877; 2160063194; 2160071203; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063990; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160059830; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160060212; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160081281; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160065902; 2160079806; 2160064120; 2160065020; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160066587; 2160071412; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081922; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160067926; 2160072756; 2160074622; 2160078027; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160082675; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160071331; 2160078237; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160066701; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160081688; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160066695; 2160076973; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160071334; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160058195; 2160059857; 2160061510; 2160062905; 2160081661; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160077103; 2160078602; 2160081098; 2160082376; 2160084416; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160065626; 2160069862; 2160065099; 2160071534; 2160078289; 2160080239; Class II Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063553; Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Devices MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit. Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015 Class II Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. Medical Components, Inc dba MedComp
Biologics Source Plasma 2160057939; 2160060444; 2160064217; 2160066580; 2160075681; 2160077624; 2160081721; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160059461; 2160063082; 2160079309; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160070284; 2160073365; 2160082085; 2160069890; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160065670; 2160067714; 2160068123; 2160068925; 2160069869; 2160076925; Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160076787; 2160077014; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160058297; 2160061514; 2160065425; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160081212; 2160078634; 2160077107; 2160078104; 2160076142; 2160076399; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160057724; 2160069744; 2160080219; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063974; 2160065035; 2160065848; 2160067663; 2160068530; 2160072197; 2160072803; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160061492; 2160062821; 2160068032; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160077758; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160072100; 2160068973; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160071149; 2160058845; 2160060422; 2160067947; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160061067; 2160058897; 2160071586; 2160072834; 2160073403; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160063932; 2160077916; 2160079346; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160069963; 2160071367; 2160074525; 2160075582; 2160076775; 2160079065; 2160079548; 2160081049; 2160083401; Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Devices Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia. Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612. Class II A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector. SALTER LABS
Food Queso Pringles, 40 g , and Cont. Neto Net Weight: 139 g( 4.9 oz) Queso /Cheese; Busting with more Flavor "Ahora con Man Sabor" Brand # 80208022,(139 G) Case Identification 2147166260, 2148166260 Brand # 80207887 ( 40 G) Case 2142166210 Class III Queso flavored Pringles, 40 gram and 139 gram sizes, sent to distribution centers in Mexico and Grenada are being recalled because the flavoring ingredient ( under a separate recall) may be contaminated with metal fragments. Pringles processing includes metal fragment seasoning screening and finished product metal detection to 1. 4 mm size. Pringle's product containing the recalled seasoning was not distributed in the United States. Kellogg Company
Food iForce Nutrition Xtreme Series, PROTEAN, Lean Protein, Strawberry Creamsicle, Dietary Supplement, 4 lbs. Mfg. for Dist by, Tribravus Enterprises, LLC, Vista, CA 92081 Lot # SP1327D2, Exp. 11/23/2013; Lot # SP 1349B2, Exp. 12/15/2013 and Lot # SP 2072B2, Exp. 03/12/2014 Class II The product contains undeclared wheat. PGP International, Inc.
Food Frozen Seasoned and Cooked Clam Meat with Hot Pepper (Item #33229120) (5kg X 2). 33229120 Class II Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Grand Supercenter Inc.
Food Frozen Oysters: 1) I.Q.F. 2 LB/12 Frozen Oyster (Permit #NJ36RS) - Item #33200115.; I.Q.F. (T-Size) 8 oz/40 Frozen Oyster (Permit #NJ36RS) - Item #33200116; BLOCK 1 LB/30 Frozen Oyster (Permit #NJ36RS) - Item #33200117. I.Q.F. (S Size) 5 LB/6 Frozen Oyster (Permit #NJ36RS) - Item #33200118. 2) Oyster 30/1 LB Frozen Oyster (Permit # NJ36RS) 3) IQF 2LB/12 Frozen Oyster and 8OZ/40 Frozen Oyster (Permit # NJ36RS). Item # 33200115; 33200116; 33200117; 33200118 Class II Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Grand Supercenter Inc.
Food Oyster 8 oz. x 40 Korea "Farm Raised" Item # 33203712 Class II Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Grand Supercenter Inc.
Food Reggano, Linguine and Parmesan Pasta Entree, NET WT 4.8 OZ(136g), UPC 4149813345, Distributed by ALDI Inc., Batavia, IL 60510. 77A04262 77A05242 Class II Based on information received from Kerry Food Ingredients and Flavours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Reggano Pasta Salad Classic, UPC 4149812863, Distributed by ALDI Inc., Batavia, IL 60510. 77A05112 77A05232 77A05302 77A05292 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Reggano Pasta Skillet Dinner Stroganoff, NET WT 5.6 OZ (158 g) UPC 4149812433, Distributed by ALDI Inc., Batavia, IL 60510 77B05152 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Food Club Pasta Salad Classics Ranch & Bacon, NET WT 7.5 OZ ( 212g), UPC 3680034311, Distributed by TOPCO ASSOCIATED, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077 77A05222 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food H.E.B Pasta Salad Ranch & Bacon, NET WT 7.5 OZ , CONT. NET 212G, UPC 4122089106 77A05072 77A05222 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Kroger, Macaroni & Cheese Rich n Creamy, NET WT 7.25 OZ (205 g), UPC 1111085149, DISTRIBUTED BY KROGER CO, CINCINNATI, OH 45202. 77C05102 77C05292 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Kroger, Macaroni & Cheese Three Cheese, NET WT 7.25 OZ (205 g), UPC 1111085146, Distributed by The Kroger Co., Cincinnati, OH 45202. 77C05112 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Meijer Macaroni & Cheese Dinner Thick"n Cheesy, NET WT 7.25 OZ (206 g), UPC 4125096335, DIST. BY MEIJER DISTRIBUTION INC. GRAND RAPIDS, MI 49544 77H05212 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Food Great Value, Thick and Creamy Macaroni and Cheese , NET WT 7.25 OZ (206g), UPC 7874223061, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716 76A05042 76A05082 76A05312 Class II Based on information received from Kerry Food Ingredients and Flav ours, Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the recalled products contained a seasoning blend manufactured by Kerry with lactic acid which may contain small metal fragments. TreeHouse Foods, Inc / Bay Valley Foods
Devices Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403 Class II During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail. Hill-Rom, Inc.
Devices Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician Manufactured between the dates of July 12, 2011 through September 2, 2011 and January 19, 2012 through May 22, 2012. Serial numbers within the ranges of: US00550047 to US00551654 and US00556357 to US00559493 respectively. There are also some additional  ...
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Class II HeartStart MRx Unexpected Pads/Paddles ECG Failure Philips Healthcare Inc.
Food Oysters Breaded/Kaki Fry, 12x2lbs, item #88250, SK Breaded Oyster 10x2lb, item#91750, and Oyster Breaded Big KOR SK F, item#91306. Item #91750, lot#DO-2012.01.15, DO-2010.01.17, DO-2010.02.22, DO-2010.02.23, DO-2010.04.23, DO-2010.02.24, DO-2010.04.24, DO-2010.03.11, DO-2010.03.12, DO-2011.01.29, DO-2011.01.30, DO-2011.03.12, DO-2011.04.03, DO-2011.04.04, DO-2011.05.08, DO-2011.05.08, DO-2011.05.18, DO-2011.05.19, DO-2012.01.14, DO.2012.01.15; and item#88250, lot code: 206419-3, 212707-4. Item#91306, Lot#DO-2011.04.04. Class II Nishimoto is recalling all Shirakiku Brand Oyster Breaded received from Korea because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they have been rendered injurious to health. Nishimoto Trading Co Ltd
Food Frozen Half Shell Oysters(S) and Frozen Half Shell Oysters(M) Lot Code#2123B(S), 2123C(M) Class II Rong Cheng Trading is recalling all Korean imported frozen shellfish because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Rong Chang Trading LLC dba: Always Best
Food Crispy by TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. UPC 6 27265 00217 6; All codes, best before March 27, 2013. Class I Product may contain undeclared milk. Indian Foods & Spices, LLC
Food Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 400 g, Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Roadt, Mississauga, Ont, Canada L4T 3M5. UPC 6 27265 001209; All codes, best before March 27, 2013. Class I Product may contain undeclared milk. Indian Foods & Spices, LLC
Food Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 400 g, Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T3M5. UPC 6 27265 006013; All codes, best before March 29, 2013. Class I Product may contain undeclared milk and almond. Indian Foods & Spices, LLC
Food Crispy TWI Foods Coconut Cookies, Biscuit, Net Wt 400 g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. UPC 627265001216; All codes, best before March 29, 2013. Class I Product may contain undeclared milk. Indian Foods & Spices, LLC
Food Crispy by TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. UPC 6 27265 00217 6; All codes, best before March 27, 2013. Class I Product may contain undeclared milk. Singh And Singh Distributors Inc.
Food Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 400g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. UPC 627265006013 best by March 27, 2013 Class I Product may contain undeclared milk and almonds. Singh And Singh Distributors Inc.
Food Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 400 g, Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Roadt, Mississauga, Ont, Canada L4T 3M5. UPC 627265005207 best by March 27, 2013 Class I Product may contain undeclared milk. Singh And Singh Distributors Inc.
Food Crispy by TWI Foods Coconut Cookies, Biscuit, Net Wt 200 g, Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5. UPC 627265005214 best by March 27, 2013 Class I Product may contain undeclared milk. Singh And Singh Distributors Inc.
Food CJ Het Oyster (CJ Frozen Oyster), 40x8oz.. Material#912329, Frozen Oyster (KR 12 SP 050110), Material#912330, Frozen Oyster (KR 12 SP 050210), Material#912331, Frozen Oyster (KR 12 SP 050310). Lot# 912329 (KR 12 SP 050110), 912330 (KR 12 SP 050210), 912331 (KR 12 SP 050310). Class II CJ Foods is recalling CJ Het Oyster (CJ Frozen Oyster) becauase it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. CJ Foods, Inc., A Division of CJ America
Food Frozen Half Shell Oysters, 144 pcs not available. Class II Khee Trading is recalling Frozen Half Shell Oysters from Korea because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Khee Trading
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