Drug and pharmaceutical recalls

17728 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-DrugPiramal Critical Care, Inc.Class II
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
2019-08-07FDA-DrugLNK International, Inc.Class II
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
Microbial contamination of non-sterile product
2019-08-07FDA-DrugMAJOR PHARMACEUTICALSClass II
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
2019-08-07FDA-DrugAmerican Health PackagingClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
Failed Dissolution Specifications: Out of specification result for the dissolution test.
2019-08-07FDA-DrugH J Harkins Company Inc dba Pharma PacClass II
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
2019-08-07FDA-DrugImprimisRx NJClass II
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Subpotent Drug
2019-08-07FDA-DrugImprimisRx NJClass II
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Subpotent Drug
2019-08-07FDA-DrugWise PharmacyClass II
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/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
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 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
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 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
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 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
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 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
Papaverine/Phentolamine 30 mg/1 mg/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
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Lack of Processing Controls
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.

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