APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
Recall Number: D-0052-2015
Firm: Valeant Pharmaceuticals North America LLC
Classification: Class III
Status: Terminated
Report Date: 20141105
Initiation Date: 20140605
Termination Date: 20170727
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Product Description
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7