Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Label does not declare walnuts in English
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Failed content uniformity specifications.
Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Undeclared Egg Allergen
Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Foreign object: products may contain glass pieces
BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
Undeclared peanuts.
Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Label does not declare walnuts in English
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
Subpotent Drug
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
Subpotent Drug
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Presence of particulate matter: glass and stopper piece
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
Subpotent Drug
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Foreign object: products may contain glass pieces
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
Undeclared peanuts.