US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 5, 2014 (12 years ago)

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Incorrect or Missing Package Insert

What was recalled

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

Recalling firm
Valeant Pharmaceuticals North America LLC
NDC code
0024-5812-07
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0053-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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