Actavis Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed to meet dissolution specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count bottles. This action is an extension of a previous recall initiated on July 31, 2013, because an additional lot was found to have similar failing results for dissolution at the 8-hour timepoint.
The affected product is distributed nationwide and in Puerto Rico. The recall involves 428,268 bottles with specific lot numbers and expiration dates ranging from December 2013 to August 2014. The product is distributed by Actavis South Atlantic, LLC, and packaged by American Health Packaging.
Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
- Manufacturer
- Actavis South Atlantic LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 428,268
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 (20)
- Lot #: CA2D14A
- CA2D15A
- Exp 12/13
- CD2D07A
- CD2D09A
- CD2D10A
- CD2D09B
- CD2D08A
- Exp 03/14
- CE2D05A
- CE2D06A
- CE2D07A
- CE2D11A
- CE2D12A
- CE2D10A
- CE2D19A
- Exp 04/14
- CF2D01A
- CF2D02A
- CF2D03A
Distribution
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