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
Recall initiated: 20140605
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated