Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets for Dissolution Failure
Actavis Inc is recalling 15,132 bottles of BuPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because dissolution test results exceeded approved limits.
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 the product is not likely to cause adverse health consequences. The issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Actavis Inc is recalling 15,132 bottles of BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count. The recall is due to failed dissolution specifications, specifically because test results at the 8-hour time-point were above approved specification limits.
The affected product is identified by Lot # CG2D18A and expiration date 06/14. The NDC is 67767-142-30 and the UPC is 3 67767-142-30 6. The product was distributed nationwide and in Puerto Rico.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
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 Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 15,132
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 (2)
- Lot #: CG2D18A
- Exp 06/14
Distribution
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