FDA recall D-66014-001

Amneal Pharmaceuticals of New York, LLC. · Class II · drug

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-08-17
Report date: 2013-11-13
Termination date: 2014-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66014-001