FDARecalled Jun 21, 2023 · #D-0876-2023
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.
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) Classification: Class II Distribution: LA, PA and OH.
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Model numbers
- HL00721A
- UPCs
- —