Valeant Recalls APLENZIN Tablets Due to Missing Package Insert
Valeant Pharmaceuticals is recalling APLENZIN extended-release tablets because the package insert is incorrect or missing. Consumers should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (missing insert) rather than a direct safety hazard.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling APLENZIN (bupropion hydrobromide) extended-release tablets, 348 mg. The recall involves 7-count and 30-count HDPE bottles. The specific reason for the recall is that the package insert is incorrect or missing.
The affected products are identified by the following lot numbers and expiration dates: Lot 13E020P (Exp. 03/17) for 7-count bottles, and Lots 13E029P, 13E028P, and 13K032P (Exp. 03/17) for 30-count bottles. The total quantity involved is 23,057 HDPE bottles. The products were distributed nationwide.
Consumers who have these products should contact their healthcare provider for instructions on how to proceed. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23,057
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 (5)
- Lot #: a) 13E020P
- Exp. 03/17 Lot #: b) 13E029P
- 13E028P
- 13K032P
- Exp. 03/17
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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