Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutica…
- Recall date
- May 30, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0876-2023
- FDA classification
- Class II
- Brand / firm
- Amneal Pharmaceuticals of New York, LLC
- Sold / distributed
- LA, PA and OH.
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
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