Actavis Recalls BuPROPion Hydrochloride Tablets Due to Dissolution Failure
Actavis Pharmaceuticals is recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets 300 mg because they failed dissolution specifications during stability testing.
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, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Actavis Pharmaceuticals is voluntarily recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg. The affected product is identified by Lot CB1D05A and NDC 67767-142-30. The recall was initiated because the tablets failed to meet dissolution specifications at the 8-hour mark during 18-month stability testing.
The recalled product was distributed nationwide. 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.
Patients who have this medication should consult their healthcare provider or pharmacist for guidance on whether to continue taking the medication or obtain a replacement. Consumers should not dispose of the medication in the trash; they should follow local regulations for the safe disposal of prescription drugs.
The recalled product
- Product
- buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
- Manufacturer
- Actavis Pharmaceuticals
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 14,856
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 (1)
- Lot CB1D05A
Distribution
Distributed nationwide across the United States.
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