FDA recall D-0053-2015

Valeant Pharmaceuticals North America LLC · Class III · drug

Product

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

Reason for recall

Labeling: Incorrect or Missing Package Insert

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-06-05
Report date: 2014-11-05
Termination date: 2017-07-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2015