Product: Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Reason for recall: Failed dissolution specifications; 18 month CRT
Recall initiated: 20130817
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated