FDA-Drug2019-11-20Class III
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Amneal Pharmaceuticals, Inc.
Hazard
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Sold states
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Affected count
2460 cartons/3 blister cards/10 capsules each
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0321-2020Don't want to check this manually?
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