Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2019-08-07FDA-DrugWise PharmacyClass II
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
2019-08-07FDA-DrugWise PharmacyClass II
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
2019-08-07FDA-DrugWise PharmacyClass II
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
2019-08-07FDA-DrugWise PharmacyClass II
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
2019-08-07FDA-DrugLupin Pharmaceuticals Inc.Class II
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class III
DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

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