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U.S. Department of Health and Human Services

Enforcement Report - Week of June 25, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Cargill Right Now Onyx (MC), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104 Manufactured at the Montgomery City, MO firm. Cargill Right Now Onyx (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104 MH -0802 Manufactured at the McPherson, KS firm. Lot Codes at Montgomery City, MO firm: 522345; 522349; 522353; 523018; 523032; 613039; 613044; 612356; 612362; 612363; 613009; 613014; 613024; and 613046. No expiration dates Lot Codes at McPherson, KS firm: Lot Code: 5222345, 522349, 522353, 523018, 523032, 613039, 613044, 612356, 612362, 612363, 613009, 613014, 613024 and 613046. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald Anaplas Fly Control (C2.4/Meth) (GY) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-C4 GY 0802 Manufactured at the Montgomery City, MO firm. Lot Code: 613039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Onyx Fly (C1.4) (GY) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methaprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-C2 GY 0802 Manufactured at the Montgomery City, MO firm. Lot Code: 613036. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C650) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-A5 MC 1301 Manufactured at the Montgomery City, MO firm. Lot Code: 613045. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C1.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-CS MC 1301 Manufactured at the Montgomery City, MO firm. Lot Code: 613058, 613037 and 613044. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald Fly (C1.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-AL MC 1301 Manufactured at the Montgomery City, MO firm. Lot Code: 613050, 613045, 613056, 613057 and 613058. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (MC) Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103 MC 1301 Manufactured at the Montgomery City, MO firm. Lot Code: 613038, 613039, 613043 and 613050. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald Anaplas (C2.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-C1 MC 1301 Manufactured at the Montgomery City, MO firm. Lot Code: 613037. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C2.0) (BIOMS) (UMW) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-P5 MC 1202 Manufactured at the Montgomery City, MO firm. Cargill Right Now Emerald (C2.0) (BIOMS) (UMW) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-P5 MH 1203, Manufactured at the McPherson, KS firm. Lot Code: 523024, 523038, 523049, 523051, 523056, 613039 and 613057. No expiration dates (same for both facilities) Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Mineral (C3500) (MH) Medicated, Active Drug Ingredient: Chlortetracycline , mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C5 MH 1103 Manufactured at the McPherson, KS firm. Lot Code: 523052. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Mineral (C2800) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C MH 1103 Manufactured at the McPherson, KS firm. Lot Code: 523028 and 523038. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazer AP (B720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-B MH 1301 Manufactured at the McPherson, KS firm. Lot Code: 523030. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers ALL Purpose (C2.0/IGR) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C6 MH 1205 Manufactured at the McPherson, KS firm. Lot Code: 523015. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers AP Mineral (MOS) (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-CM MH 1103 MOS Manufactured at the McPherson, KS firm. Lot Code: 523014. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Mineral (C4000) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C3 MH 1103 Manufactured at the McPherson, KS firm. Lot Code: 523002, 523015 and 523046. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Fescue Mineral (C1.4) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-FT MH 1206 Manufactured at the McPherson, KS firm. Lot Code: 523008. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (P) (C2.0/IGR) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-GG MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523058. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Mineral CFLY (C1.4) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-CE MH 1302 Manufactured at the McPherson, KS firm. Lot Code: 523058. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (W) (MH), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-W MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523050. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N2 MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523044 and 523056. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (PNW) (AVL) (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-NH MN 1203 Manufactured at the McPherson, KS firm. Lot Code: 523039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (Altosid IGR) Active Ingredient: S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-GR MH Manufactured at the McPherson, KS firm. Lot Code: 2MK3045 and 2MK3051. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (PNW) Complex (MH), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N1 MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (B1440) MOS CHEL (MH) Medicated, Active Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-NF MH 1201 Manufactured at the McPherson, KS firm. Lot Code: 523044. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C2.0) MOS (MH) Medicated, Active Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N3 MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523044. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (PNW) (MOS) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N8 MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 523042 and 523050. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Breeding Herd Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92428 MH 1206 Manufactured at the McPherson, KS firm. Lot Code: 523047. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Winter Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 80678 MH 1207 Manufactured at the McPherson, KS firm. Lot Code: 523010, 523021 and 523039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C2.0) (W) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-WS MH 1202 Manufactured at the McPherson, KS firm. Lot Code: 523046. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Onyx (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-N MH 1210 Manufactured at the McPherson, KS firm. Lot Code: 523044. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Nutrebeef Stocker Summer Mineral (C1.4) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92111-C MH 0707 Manufactured at the McPherson, KS firm. Lot Code: 523046. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Onyx Min (P) (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-CC MH 1112 Manufactured at the McPherson, KS firm. Lot Code: 522348 and 523036. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Summer Mineral (B720) (MH), Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92111-L MH 0807 Manufactured at the McPherson, KS firm. Lot Code: 523037 and 523039. No expiration dates Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Onyx (P) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-P MH 1203 Manufactured at the McPherson, KS firm. Lot Code: 522347, 522356, 523008, 523023, 523028, 523030, 523036, 523044, 523047 and 523058. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers APC Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144 MH 1103 Manufactured at the McPherson, KS firm. Lot Code: 523008, 523023, 523030, 523035 and 523052. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Cattle Grazers All Purpose Fescue Mineral (UMW) (M800) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 7144-P3 MH 1302, Manufactured at the McPherson, KS firm. Lot Code: 523037. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (P) (CHLT) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-CH MH 1203, Manufactured at the McPherson, KS firm. Lot Code: 523038. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (P) (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-CH MH 1203, Manufactured at the McPherson, KS firm. Lot Code: 523038. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald Fescue (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-FT MH 1201, Manufactured at the McPherson, KS firm. Lot Code: 523038, 523047 and 523058. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (M600) (UMW) (MH), Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-PH MH 1301, Manufactured at the McPherson, KS firm. Lot Code: 523038. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (M1200) (UMW) MOS (MH), Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-RZ MH 1203, Manufactured at the McPherson, KS firm. Lot Code: 523038. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (P) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-P MH 1203, Manufactured at the McPherson, KS firm. Lot Code: 523039, 523035, 523044, 523047 and 523056. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Right Now Emerald (C3.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline. Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-WK MH 1207, Manufactured at the McPherson, KS firm. Lot Code: 523046. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Summer Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92111 MH 1301, Manufactured at the McPherson, KS firm. Lot Code: 523010. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Summer Mineral (M610) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92111-R MH 1212, Manufactured at the McPherson, KS firm. Lot Code: 523015. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Wheat Mineral W/THIA (B720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-L3 MH 1201, Manufactured at the McPherson, KS firm. Lot Code: 522361. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Wheat Mineral (M600) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-R MH 1208, Manufactured at the McPherson, KS firm. Lot Code: 522352 and 523015. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Veterinary Cargill Stocker Wheat Mineral (M720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-L MH 1105, Manufactured at the McPherson, KS firm. Lot Code: 522347, 522352, 522362, 523002, 523009 and 523015. No expiration dates. Class I The product does not contain Vitamins A, D, and E as indicated on the label. Cargill, Inc
Devices "***NIPRO Safe Touch Safety Scalp Vein Set STERILIZED WITH ETO GAS Intended to be used for insertion into a patient's vascular system as an indwelling device to administer fluids intravenously or to sample blood. Product Code: PR+25G19; Lot #12H31H (7,000) Product Code: PR+25G19; Lot #12l14H (2,000) Product Code: PR+25G19; Lot #12Hl24 (10,000) Product Code: PR+25G19; Lot #12J11 (9,000) Product Code: PR+25G19; Lot #12H27H (150,000) Product Code: PR+25G19; Lot #12l12H (100,000) Class II There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids. Nipro Medical Corporation
Devices Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear Serial Numbers: 00174-1030010, 01839-1257619, 01249-1 013988, 00036-1175608, 01052-1100006, 00359-1150914, 03283-1 055954, 00773-1 043248, 05385-1 051400, 00644-1151291, 02402-1 028575, 01903-1041038, 02294-1 024246, 03729-1 020577, 02937-1071566 Class II Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings. Wal Mart Stores, Inc
Food Tam Tams Snack Crackers Unsalted Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box 0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a Class III The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity. R.A.B. Food Group LLC
Food Tam Tams Snack Crackers Onion Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box 0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a Class III The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity. R.A.B. Food Group LLC
Food Tam Tams Snack Crackers Garlic Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box 0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a Class III The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity. R.A.B. Food Group LLC
Food Tam Tams Snack Crackers Everything Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box 0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a Class III The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity. R.A.B. Food Group LLC
Food Tam Tams Snack Crackers Original Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box 0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a Class III The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity. R.A.B. Food Group LLC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W118813535756; W118813535793; W118813555836; W118813555848; W118813555848; W118813562328; W118813575223; W118813575223 Class II Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W118813535445; W118813202282; W118813202282; W118813202286; W118813202286; W118813202358; W118813202358; W118813401945; W118813401945; W118813401961; W118813401961; W118813503402; W118813503415; W118813503421; W118813503502; W118813503502; W118813503531; W118813503531; W118813503539; W118813503539; W118813503552; W118813503569; W118813517689; W118813517776; W118813517777; W118813525161; W118813525161; W118813525265; W118813525282; W118813525288; W118813525310; W118813525310; W118813525351; W118813525469; W118813525488; W118813525488; W118813535458; W118813535459; W118813535459; W118813535485; W118813535485; W118813535518; W118813535554; W118813535602; W118813535649; W118813535651; W118813535651; W118813535664; W118813535768; W118813535793;  ...
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Class II Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W118813575434; W118813575463; W118814510675; W118814530266 Class II Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W118814550057; W118814550075; W118814550110; W118814550054; W118814550115; W118814550127; W118813575373; W118813575405; W118813575434; W118813575444; W118813575463; W118814200029; W118814200029; W118814200047; W118814200056; W118814200056; W118814200069; W118814200069; W118814400035; W118814500002; W118814500002; W118814500005; W118814500015; W118814500015; W118814500045; W118814500067; W118814500137; W118814500137; W118814500148; W118814500153; W118814500160; W118814500160; W118814500162; W118814500162; W118814500167; W118814500167; W118814500168; W118814500168; W118814500171; W118814500171; W118814500256; W118814500256; W118814510065; W118814510065; W118814510173; W118814510206; W118814510238; W118814510238; W118814510281;  ...
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Class II Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W118814560070; W118814570203; W118814570204- part 1; W118814570204- part 2 Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W118814550127; W118814550163; W118814550168; W118814550169; W118814550179; W118814550181; W118814550181; W118814550199; W118814550199; W118814550203; W118814550203; W118814550204; W118814550208; W118814550210; W118814550224; W118814550225; W118814550225; W118814550229; W118814550229; W118814570094; W118814550233; W118814550239; W118814550242; W118814550242; W118814550269; W118814550272; W118814550321; W118814550415; W118814550415; W118814550420; W118814550452; W118814550466; W118814560035; W118814560035; W118814560064; W118814560064; W118814560104; W118814560105; W118814570148; W118814560126; W118814560132; W118814570052; W118814570052; W118814570074; W118814570074; W118814570088; W118814570132; W118814570132; W118814570137;  ...
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Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. The Blood Alliance, Inc.
Devices Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. All lot numbers of multiple part numbers:293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.48L 293.48X 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.62 293.63 293.67 293.68 293.69 293.72 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.30SHA 294.43 294.43SHA 294.44 294.44SHA 294.45 294.455 294.45SHA 294.46 294.46SHA 294.48 294.52 294.52SHA 294.53SHA 294.54 294.54SHA 294.55 294.55SHA 294.56 294.56SHA 294.57 294.57SHA 294.65 294.66 294.67 294.67SHA 294.68 294.68SHA 294.71 294.72 294.73 294.73SHA 294.74 294.74SHA 294.75 294.75SHA 294.76 294.767 294.768 294.769 294.769SHA 294.76SHA 294.771 294.771SHA 294.772 294.772SHA 294.773 294.774 294.775 294.775SHA 294.776 294.776SHA 294.777 294.777SHA 294.778 294.778SHA 294.779 294.779SHA 294.782 294.782SHA 294.783 294.783SHA 294.784 294.784SHA 294.785 294.785SHA 294.786 294.786SHA 294.788 294.788SHA 294.792 294.792SHA 294.793 294.793SHA 294.794 294.794SHA 294.795 294.795SHA 294.796 294.796SHA 294.798 294.798SHA 494.769 494.771 494.771SHA 494.772 494.772SHA 494.774 494.775 494.775SHA 494.776 494.776SHA 494.777 494.777SHA 494.778 494.778SHA 494.779 494.779SHA 494.782 494.782SHA 494.783 494.783SHA 494.784 494.784SHA 494.786 494.786SHA 494.788 494.788SHA 494.792 494.793 494.794 494.795 494.796 494.798 294.950 293.790 293.840 293.890 293.940 390.002 390.003 390.004 390.005 390.006 390.007 390.008 390.009 390.010 390.011 390.012 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 494.785 494.785SHA 390.041 390.042 395.60 395.61 395.62 395.63 395.64 395.65 395.66 395.67 395.680 395.681 395.682 395.685 395.686 395.687 395.688 03.301.010s 03.301.011s 03.301.012s 03.301.013s Class II Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. Synthes, Inc.
Devices GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status. Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262 6705263 6705264 6705266 6705271 6705274 6705276 6705277 6705278 6705279 6705280 6705282 6705283 6705284 6705287 6705313 6705316 6705327 6705328  ...
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Class II Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out". GE Healthcare, LLC
Biologics Fresh Frozen Plasma 2029395 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced 2029395 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Central California Blood Center
Veterinary Petrem, lot S2991K16 Sevoflurane, USP , 250 mL, packaged in an amber glass vial, NDC 60307-320-25, for use in dogs, ANADA 200-438, manufactured by MINRAD, INC., Bethlehem, PA. Piramal Inc is the actual manufacturing site dba as MINRAD, INC. since 2009. lot S2991K16 , exp 11/2016. Class III One lot of Petrem was recalled due to retained material not meeting the Acidity/Alkalinity specifications as set forth in the USP Monograph for Sevoflurane. Piramal Critical Care, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W203414011837; W203414020459 Class III Blood products, which were labeled with an incorrect expiration date, were distributed. American National Red Cross ARC Blood Services N.E. Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W203414022292 Class III Blood products, which were labeled with an incorrect expiration date, were distributed. American National Red Cross ARC Blood Services N.E. Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated W201114001693; W201114031135 Class III Blood products, labeled with the incorrect expiration date, were distributed. American Red Cross Blood Services
Biologics Source Plasma OL0389425 Class III Blood product, collected from a donor for whom there was no documentation of an arm inspection or general donor appearance, was distributed. DCI Biologicals Orlando LLC
Biologics Red Blood Cells Leukocytes Reduced W126213008846 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Council of New Jersey, Inc.
Biologics Fresh Frozen Plasma W126213008846 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Council of New Jersey, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W2041140102461 Class III Blood products, labeled with the incorrect expiration date, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Irradiated W204114008316 Class III Blood products, labeled with the incorrect expiration date, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced W20291403103000; W20291400499100 Class III Blood products, which were labeled with an incorrect expiration date, were distributed. American Natl Red Cross Mid Atlantic Region
Biologics Red Blood Cells W121614121670 Class III Blood product, collected from a donor without documenting the body temperature, was distributed. The Blood Connection, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W201614019112; W201614014541 Class III Blood product, which was labeled with an incorrect expiration date, was distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing W036810058843 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036810058843; W036811019309 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036811802914 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036811019309 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W201914016019 Class III Blood product, which was labeled with an incorrect expiration date, was distributed. American Red Cross Blood Services Tennessee Valley Region
Devices RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. Software version 4.0.3.4 Class II This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution. RAYSEARCH LABORATORIES AB
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W041913042347D-part 1; W041913042347D- part 2 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W120613405578 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Michigan Blood
Biologics Source Plasma OL0390791; Class III Blood product, collected from a donor taking the medication Accutane, was distributed. DCI Biologicals Orlando LLC
Food Caravelle CHILI POWDER HOT Net Weight 8 oz. (227G), plastic tub, UPC 080736115551. 24 units/case Lot Code# 560916, 570115 Class I Anhing Corporation is recalling Caravelle Brand Chili Powder because it has the potential to be contaminated with Salmonella. Anhing Corporation
Biologics Fresh Frozen Plasma (Apheresis) W088414200619 Class II Blood products, collected from a donor who was taking the medication Proscar, were distributed. Blood Bank Of Hawaii
Biologics Platelets Pheresis Leukocytes Reduced W117014118965; W117014118965 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Fresh Frozen Plasma (Apheresis) W117014118965 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Platelets Pooled Leukocytes Reduced W036812845144 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036812565452 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812565452 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 110007380 Lot 223570 and 803860 Class II The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Biomet, Inc.
Devices EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 110007379 Lot 060830 and 258920, Class II The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Biomet, Inc.
Devices EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056. Part # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and  ...
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Class II The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Biomet, Inc.
Veterinary CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 9% Povidone-iodine (USP) Surgical Hand Scrub; NDC 57613-003-18. Packaged 30 scrub brushes per carton and 10 cartons per corrugate box. 1) Catalog Code: 4451B; Lot Numbers and Expiry Dates: 0000503318 , Expires 2013-12 ; 0000506214 , Expires 2013-11 ; 0000508533 , Expires 2013-11 ; 0000510764 , Expires 2013-11 ; 0000510935 , Expires 2013-11 ; 0000512731 , Expires 2013-12 ; 0000515176 , Expires 2013-12 ; 0000519658 , Expires 2013-12 ; 0000520682 , Expires  ...
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Class II CareFusion is conducting a voluntary recall regarding the CareFusion Scrub Care Surgical Scrub Brush- Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label and therefore does not meet the label claim for free iodine concentration. Carefusion 2200 Inc
Veterinary CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 15% Povidone-iodine (USP) Surgical Hand Scrub; NDC 57613-013-15. Packaged 30 scrub brushes per carton and 10 cartons per corrugate box. Catalog Code: 4452B; Lot Numbers and Expiry Dates: 0000503811 ,  ...
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Class II CareFusion is conducting a voluntary recall regarding the CareFusion Scrub Care Surgical Scrub Brush- Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label and therefore does not meet the label claim for free iodine concentration. Carefusion 2200 Inc
Drugs Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 All lot codes Class II Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. Thorne Research Inc
Drugs Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1 All lot codes Class II Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. Thorne Research Inc
Devices Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. 989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384 Class II The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed. Childrens Medical Ventures
Food Market Basket, Dairy-Free, Gluten-Free Pancakes. Each package contains 12 pancakes in a 14.4 oz. (408 g) box with UPC 4970571120 All lots Class I Undeclared milk in Dairy-Free, Gluten-Free Market Basket Pancakes Middle East Bakery, Inc.
Devices APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens. Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015. Class III Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens." Gen-Probe Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W044613208896; W044613317945; Class III Blood products, collected from a donor with a history of polycythemia, were distributed. Gulf Coast Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced 9782524; W044609227288; W044610307374; W044611400719; W044610338880; W044608220474; Class III Blood products, collected from a donor with a history of polycythemia, were distributed. Gulf Coast Regional Blood Center
Devices Synergy XVI Intended for radiation therapy treatment. XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1 Class II XVI can incorrectly calculate the target position of the treatment table. Elekta, Inc.
Food Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule TOTAL ENZYMES Product # 2404 LOT#S 302152, 303083, 306046, 308044(PARTIAL) Class II Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol. Nutrition Center, Inc. dba Nutri-West
Food Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule TOTAL PROBIOTICS Product # 2405, 2405A LOT#S 305002, 305001, 305036, 306015, 306045, 306109, 306110, 307018, 307019, 307065, 307066, 308009, 308010, 308121, 308122, 309063(PARTIAL) Class II Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol. Nutrition Center, Inc. dba Nutri-West
Food Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this product. Product is not coded. Class II Firm has been cold smoking, vacuum packaging, and distributing frozen seafood products without the required operating permit and without HACCP controls in place. Kodiak Wild Alaska Seafood
Food Pacific halibut, skin-on boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on the product.. Product is not coded. Class II Firm has been cold smoking, vacuum packaging, and distributing frozen seafood products without the required operating permit and without HACCP controls in place. Kodiak Wild Alaska Seafood
Veterinary HAPPY HIPS TILAPIA WITH GLUCOSAMINE & CHONDROITIN, 15 oz. All Lot with Best Before date of December 26th, 2014 or earlier, based on last lot code produced. UPC 84244115184. Product Code 11518. Class III Dogswell LLC initiated this market withdrawal due to undeclared vegetable glycerin. Dogswell Llc
Drugs Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01 Lot F0067 exp. 06/14, F0079 exp. 04/15 Class III Failed Stability Specification; out of specification result for particle size distribution during stability testing. Novartis Pharmaceuticals Corp.
Devices VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent. Lots 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), 1764 (31-Jul-2015) Class II Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28. Ortho-Clinical Diagnostics
Devices VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016) Class II Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28. Ortho-Clinical Diagnostics
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W1428140056521; W1428140056521; Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W142814010295M; W142814008359000 Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W142814010039H; W142814010039H; Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Plasma Frozen W1428140102631; W142814007828R; W1428140106636; W142814001338B; W142814005611J; W142814010278O; W142814010295M; W1428140031988; W142814004463R; W142814001994L; W1428140019428; W142814001592K; W1428140011967; W1428140003402; W14281400166200O; W14281304582200Y; W14281400326800C; W14281400244400S Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Platelets Pheresis Leukocytes Reduced W142814005824U; W142814005824U; Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced W1428140102631; W142814007828R; W142814010193Y; W142814010197Q; W142814007544E; W142814007371O; W142814007318Y; W142814005611J; W142814010278O; W142814007275O; W142814010267U; W142814010453Q; W142814004463R; W142814011086O; W1428140013559; W142814005756M; W142814007946F; W1428140031988; W14281401301400O Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Biologics Fresh Frozen Plasma (Apheresis) W142814004689S; W142814004689S; W142814004689S; W142814004689S; W1428140017103; W1428140017103; W1428140017103; W142813038174D; W142813038174D; W142813038174D; W142813038174D; W142813038002G; W142813038002G; W142813038002G; W142813038002G; W142813038002G; W1428130377209; W1428130377209; W1428130377209; W1428130377209; W1428130377209; W142813037427J; W142813037427J; W142813037427J; W142813037427J; W142813037427J; W142814010913002; W142814010913002; W142814010913002 Class II Blood products, collected from an ineligible donor, were distributed. Blood Systems, Inc
Food liveGfree Gluten Free Blueberry Pancakes NET WT 14.4 OZ, 12 pancakes Keep Frozen Distributed By Aldi, Inc., Batavia, IL 60510 Best By: 07/31/2015, UPC code 041498151485 Class I American Waffle Company of Clayton, Delaware is voluntarily recalling one lot of Gluten Free Blueberry Pancakes because the product contains undeclared milk. American Waffle
Devices Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician. 13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM513636 13VM513642 13VM516733 13VM520039 13VM521731 13VM521733 13VM524363 13VM524364 13VM527149 13VM527150 13VM528992 13VM528994 13VM531214 14FM0301 14VM531935 14VM532098 Class I Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative to the inflation and deflation of the device's retention balloon. Convatec Inc.
Devices Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. 1305-31, 1305-21, 1305-22, 1308-35, 1308-36, 130833, 130834, 1308-44, 1310-20, 1418-12, 1307-33, 1421-11, 1417-20, 1423-16, 143115, 1428-07, 1430-16, 1430-17, 1423-15, 1429-15, 1305-40, 1541-05, 1539-15, 1548-15, 1544-11, 1431-14, 1548-17, 1545-03, 1547-20, 1557-12, 1544-06, 1548-08, 1429-13, 1303-31, 1303-32, 1556-16, 1549-04, 1548-16, 1540-20, 1538-10, 1563-06, 1556-17, 1539-13, 1539-14, 1571-12, 1572-19, 1684-05, 1570-14, 1571-13, 1679-13,  ...
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Class II Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. Roche Diagnostics Operations, Inc.
Devices cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. 1848-01, 1848-03, 1848-04, 185503, 1845-15, 186211, 1857-12, 186225, 1862-16, 1862-10, 185715, 185817, 1865-05, 1862-27, 1858-35, 1859-30, 1859-33, 1863-05, 1867-14, 1844-16, 1868-14, 1844-15, 1870-06, 1870-14, 1857-13, 1870-05, 1868-08, 1867-16, 1868-02, 1865-04, 1867-13, 1862-24, 1872-14, 1872-15, 1871-05, 1873-05, 1871-12, 1871-14, 1873-10, 1872-01, 1871-09, 187015, 1873-01, 1871-04, 187113, 187202, 1871-07, 1873-02, 1866-13, 185731,  ...
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Class II Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. Roche Diagnostics Operations, Inc.
Devices cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. 1125-07,1017-06,1021-03,1021-05,1016-05,1017-01,1124-05,1124-06,1128-02,1132-03,1132-04,1131-08,1132-01,1132-02,1128-05,1128-06,2374-11,1132-05,1132-10,1137-02,1139-08,1139-10,1140-07,1140-10,1140-08,1146-01,1146-02,1146-03,1139-06,1139-07,1139-09,1142-09,1145-10,1138-10,1139-01,1127-08,1138-08,1146-05,1146-06,1147-04,1156-04,1140-01,1147-05,1149-01,1149-07,1149-08,1167-02,1156-06,1158-09,1156-05,1158-10,1139-02,1139-03,1139-04,1139-05,1160-01,1160-05,1171-07,1171-08,1171-09,1173-10,1156-01,1160-04,1156-07,1156-02,1156-09,1160-06,1171-10,1173-01,1169-06,1169-08,1169-09,1172-09,1182-08,1211-15,1211-14,1174-08,1160-08,1171-06,1174-06,1174-07,1211-13,1211-06,1183-04,1217-09,1225-11,1211-16,1211-17,1211-18,1224-10,1156-08,1156-10,1225-14,1331-13,1338-15,1338-16,1211-19,1211-04,1211-05,1211-20,1208-08,1208-09,1211-02,1211-03,1338-12,1338-13,1338-14,1208-05,1211-07,1211-08,1458-04,1331-10,1331-11,1331-12,1334-15,1335-13,1344-02,1344-03,1344-04,1344-05,1344-06,1357-07,1357-08,1357-09,1357-10,1357-19,1357-20,1334-12,1334-13,1334-14,1459-12,1459-13,1357-15,1357-16,1357-17,1357-18,1335-08,1335-09,1335-10,1335-11,1344-01,1344-07,1344-08,1461-01,1461-02,1344-09,1459-14,1459-10,1459-11,, ,  Class II Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. Roche Diagnostics Operations, Inc.
Veterinary Essentials Mouse & Young Rat Food, packaged in 2.5-lb. flexible plastic bags (12/case), UPC 744845404042, and 25-lb. flexible plastic bags, UPC 744845404035. Manufactured by Oxbow Animal Health, Oxbow Enterprises, Inc., Murdock, NE. Best by dates: Jan 10 2016, Jan 25 2016, Feb 28 2016, Mar 14 2016, and Apr 04 2016. Class III Some of the bags of product contain mold Oxbow Enterprises
Devices G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN:110003458 PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201. Class II Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. Biomet, Inc.
Devices G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis PN 110003500. PN: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877. Class II Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. Biomet, Inc.
Devices Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary. Model Numbers: 9896 030 1929.2, 9896 030 1929.3 Class II Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF. Philips Medical Systems, Inc.
Devices Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary. Model Number: 9896 030 1929.1 Class II Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF. Philips Medical Systems, Inc.
Devices VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results. Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528 Class III The keyboard and monitor may not be properly secured to the monitor arm. Siemens Medical Solutions Diagnostics
Food Bulk shelled walnuts packaged in 25 lb. cardboard boxes labeled with GSF LLC, Combo Halves and Pieces, Visalia, CA. 4024 CHP, also labeled California Walnut Board 40242096 Lot # 129498 Class I The products are potentially contaminated with Listeria monocytogenes Sherman Produce Co
Food Schnucks walnuts packaged in 10 oz. plastic trays. IPC 003383900325 Packed by Sherman Produce Company, St. Louis, MO. Lot # 129498 , best by dates 03/15 and 04/15 Class I The products are potentially contaminated with Listeria monocytogenes Sherman Produce Co
Devices MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. N/A - Software versions 1.40 through 2.50, inclusive Class II When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen. Elekta, Inc.
Food Whole Foods Thai Soba Noodle Salad , 9 oz. refrigerated plastic container UPC Code: 36406304107 Use By; 05/25/14 Class I Thai Soba Noodle Salad contains undeclared soy Whole Foods Market Group Inc.
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4500; Material Number: M004PM45000; Serial numbers: 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, 16872836. Expiry Dates: May 7, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4500N4; Material Number: M004PM45000N40; Serial numbers: 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, 16872124. Expiry Dates: May 11, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 Expiry Dates: May 11, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4790K2; Material Number: M004PM47900K2; Serial numbers: 16739673, 16739674, 16739675, 16739676, 16739677, 16739678, 16739679, 16739860, 16872121, 16872935 Expiry Dates: May 11, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Catalog Number: PM4790N4; Material Number: M004PM47900N4; Serial numbers: 16743269, 16872007; Expiry Dates: May 11, 2014 to January 13, 2017 Class II Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Boston Scientific Corporation
Devices Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 Serial Numbers Distributed in the US: 436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283,  ...
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Class II Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor. Spacelabs Healthcare Inc
Food GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces 4024CHP Class I FDA sample found positive for Listeria monocytogenes. GSF Nut Company LLC
Food Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), UPC 09513-00008 Sell by Dates: 05211411, 04051408, 06191415, 06191416, 06191417, 06261411, 06261412, 07071413, 07071414, 08061410, 08121406, 08121407, 08281413, 08281414, 08281415, 08281416, 09201411, 10031410, 10111404, 10171408, 10171409, 10251413, 11011406, 11151409. Class II 8 oz tubs of Fayette Creamery brand Jalapeno Raw Milk Cheddar Cold Pack Cheese contains an undeclared soy ingredient. Brunkow Cheese of Wisconsin, Inc.
Drugs TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46 Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16 Class II Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process. Ferring Pharmaceuticals Inc
Food Product label: Amport Foods, Granola, Cinnamon Crunch, 22 oz (1 lb, 6 0z), UPC 0 71725 72511 0, Best BY 03-26-15, Ingredients: wheat flakes, oat flakes , brown sugar, sugar, coconut oil, coconut, wheat flour, cinnamon, honey, natural vanilla, sea salt. Allergy Information: This product is produced on packaging equipment shared with peanut and tree nut products. Case label: Stock No. 3250420 8/22 oz, Amport Vanilla Almond Granola, Best by 3-26-15, 085X418, UPC 3 00 71725 72512 8. Best By 03-26-15. Lot Code: 085x418. Class II American Importing Co, Inc is voluntarily recalling a limited number of packages of a single lot of Cinnamon Crunch Granola because they may contain undeclared almonds. People who have an allergy or sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product. No adverse reactions or illnesses have been reported to date. American Importing Co, Inc
Biologics Cornea PH116682OS; PH116682OD; PH116909OD; PH116965OS; PH116979OS; PH116877OD; PH117171OS; Class II Human Corneas, processed using an expired viewing chamber, were distributed. Saving Sight
Devices Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries. Part Number 29948, Lot Number 3-1294. Expires October 2016 Class II Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use. Kerr Corporation
Devices iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. Software Versions 2.0.0, 2.0.1 and 2.0.2 Class II A bug in the software prevents the iGUIDE software from logging off. Elekta, Inc.
Biologics Cornea 140304ODC; 140304OSC; Class III Human Corneas, processed with a corneal preservation media that was not verified to meet specification for use, were distributed. Minnesota Lions Eye Bank, Inc
Drugs Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15. Lot #: 3100135, Expiry: 05/2014 Class II Subpotent Drug. Actavis Inc
Devices Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L, Class II In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. Catalog Number 14-501669; Lot Number 006731 Class II The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Ebi, Llc
Devices RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use Serial Numbers: B1400045 B1400085 B1400272 B1400352 B1400101 B1400344 B1300083 B1400133 B1400114 B1300030 B1400290 B1400297 B1400197 B1400305 B1300043 B1400264 B1300080 B1400024 B1400087 B1300073 B1400108 B1400330 B1400138 B1300056 B1400261 B1400210 B1400321 B1400337 B1400300 B1400323 B1400351 B1400103 B1400104 B1400156 B1400173 B1400202 B1400222 B1400232 B1400253 B1400269 B1300062 B1400296 B1400258 B1400083 B1400111 B1300084 B1400135 B1400294 B1400031 B1400036 B1400162 B1300082 B1400102 B1400050 B1400051 B1400076 B1400084 B1300038 B1300025 B1400288 B1400280 B1400281 B1400312 B1400018 B1400252 B1400245 B1400260 B1400128 B1400201 B1400215 B1400308 B1400071 B1400033 B1400058 B1400213 B1400196 B1400214 B1400203 B1400204 B1400115 B1400212 B1400144 B1400319 B1400238 B1300072 B1300074 B1400336 B1400335 B1300061 B1400174 B1400175 B1400171 B1400194 B1300050 B1400059 B1400025 B1300036 B1400074 B1400089 B1400234 B1400346 B1400010 B1300065 B1400055 B1400064 B1300048 B1400151 B1400066 B1400090 B1400118 B1400119 B1400147 B1300029 B1300064 B1400227 B1400230 B1400231 B1400152 B1400153 B1300032 B1400216 B1400239 B1400241 B1400242 B1300075 B1400020 B1400298 B1400311 B1300023 B1400338 B1400340 B1400134 B1400143 B1400005 B1400289 B1300060 B1400105 B1400225 B1400332 B1400141 B1400154 B1400043 B1400098 B1400181 B1400318 B1400223 B1400220 B1400339 B1400182 B1400268 B1400334 B1300026 B1400049 B1400046 B1400047 B1400052 B1400249 B1400027 B1300047 B1300051 B1300053 B1400155 B1400310 B1400160 B1300079 B1300066 B1400015 B1400350 B1400273 B1400185 B1400250 B1400322 B1400061 B1300035 B1400168 B1300004 B1300005 B1300009 B1300010 B1300014 B1300015 B1300016 B1300020 B1400270 B1400271 Class II Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure. Ability Dynamics LLC
Drugs Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot# 938, Use by 08/17/14, Lot #1370; Use by Lot# 1818; Use by 11/08/14, 1/30/15; Lot# 2664, Use by 4/18/15 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot # 940, Best used by 08/01/14; Lot # 1090, Best used by 08/29/14; Lot # 1533, Best used by 05/24/14; Lot # 1838, Best used by 07/15/14; Lot# 2755, Best used by 10/06/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 lot# 1157, Use by 09/16/14; lot# 2357, use by 06/01/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot: 1731, Use by 7/01/14; Lot: 2190, Use by 8/24/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot # 1862, used by 7/20/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14;  ...
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Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot # 2095, Use by 8/17/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 a) 5 mL: Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14; Lot: 2672, best used by 7/03/14; Lot: 3022, best used by 7/28/14; b) 10 mL: Lot: 2166, best used by 5/26/14; Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot: 2187, best used by 05/26/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 a) 5 mL: Lot: 2488, best used by 6/19/14; b) 10 mL: Lot: 2264, best used by 06/03/14; Lot: 2295, best used by 06/04/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234 a) 5 mL: Lot: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14; Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234 lot: 2571, use by 9/23/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 Lot: 2789, Best used by: 7/10/14 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
Drugs Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234 Lot 2868, Best used by 3/15/15 Class II Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. John W Hollis Inc
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