AvKARE recalls
10 recalls on record · 1 rated Critical · FDA
Every recall we have on record for AvKARE, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only,…
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and…
Failed Content Uniformity Specifications
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx…
Presence of a foreign substance.
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE,…
Failed Impurity/Degradation Specifications
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx…
Failed Dissolution Specifications
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops,…
LABELING: LABEL MIX-UP
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only,…
Failed Dissolution Specifications
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,…
Labeling: Label Mix-Up
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,…
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx…
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.