Amneal Pharmaceuticals of New York, LLC. recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11
Recalled November 13, 2013 · FDA recall D-66014-001 · Amneal Pharmaceuticals of New York
Hazard
Failed dissolution specifications; 18 month CRT · FDA Class II
Units
895 - 1000 count bottles
Sold at
IL, NH, NJ, NY, OH, RI, TN
Description
Failed dissolution specifications; 18 month CRT
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
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →