FDA recall D-0516-2019

Amerigen Pharmaceuticals Inc. · Class III · drug

Product

Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071

Reason for recall

Failed dissolution specifications

Distribution

Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.

Key facts

Status: Terminated
Initiation date: 2019-02-19
Report date: 2019-02-27
Termination date: 2019-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lyndhurst, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2019