Valeant Recalls APLENZIN Tablets Due to Missing Package Insert
Valeant Pharmaceuticals is recalling APLENZIN (bupropion hydrobromide) extended-release tablets because the package insert is incorrect or missing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to packaging/labeling documentation.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling APLENZIN (bupropion hydrobromide) extended-release tablets, 522 mg, in 7-count and 30-count HDPE bottles. The recall is due to a labeling issue where the package insert is incorrect or missing.
The affected product is prescription-only and was distributed nationwide. The recall involves 55,650 HDPE bottles across multiple lot numbers and expiration dates ranging from 07/15 to 10/16.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- 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
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 55,650
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #: a) 13E023P
- Exp. 03/16 Lot #: b) 12J063P
- Exp. 07/15 12K063P
- Exp. 09/15 12K060P
- Exp. 07/15 12M073P
- Exp. 09/15 13A036P
- Exp. 11/15 13B035P
- Exp. 11/15 13C046P
- Exp. 11/15 13D060P
- Exp. 11/15 13E030P
- Exp. 03/16 13E031P
- Exp. 03/16 13F003P
- Exp. 03/16 13K034P
- Exp. 03/16 14A001P
- Exp. 10/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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