Recall: D-66014-001

Class II - Potentially Harmful

Class IIClassification

2013-08-17Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

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

Failed dissolution specifications; 18 month CRT

Distribution

IL, NH, NJ, NY, OH, RI, TN

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.