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.
Reason for recall: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Recall initiated: 20230530
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated