Amneal Pharmaceuticals, Inc. recalls Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distribute…
- Recall date
- October 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0321-2020
- FDA classification
- Class III
- Brand / firm
- Amneal Pharmaceuticals, Inc.
- Sold / distributed
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Why it was recalled
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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