Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets Due to Dissolution Failure
Actavis South Atlantic LLC is recalling 555,672 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed USP dissolution test requirements.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and no illnesses or injuries are reported in the source text.
Plain-English summary
Actavis South Atlantic LLC is recalling 555,672 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg. The product is distributed nationwide and is available by prescription only. The recall involves specific lot numbers with expiration dates ranging from March 2013 to November 2013.
The recall was initiated because the tablets failed USP dissolution test requirements, specifically showing out-of-specification dissolution results at the 8-hour stability testing point. This indicates that the medication may not dissolve and release the active ingredient as intended.
Consumers who have this medication should stop using it and 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.
- Manufacturer
- Actavis South Atlantic LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 555,672
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 #: CC1D11A
- CC1D12A
- CC1D17A
- CC1D18A
- CD1D05A
- CD1D07A
- CD1D08A
- CD1D14A
- CD1D15A
- CD1D16A
- CE1D08A
- Exp 03/13
- CE1D03A
- CE1D04A
- CE1D07A
- CE1D06A
- CE1D05A
- CE1D13A
- CE1D14A
- CE1D15A
Distribution
Distributed nationwide across the United States.
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