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

FDA recall notice · announced November 13, 2013 · Amneal Pharmaceuticals Of New York

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: IL, NH, NJ, NY, OH, RI, TN
Lot/code information: Batch/Lot HL50611, exp. 1/2014
Quantity: 895 - 1000 count bottles
Status: Terminated
Products in this recall event:
- 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 Distribute (D-66014-001)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.