Actavis Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure
Actavis Inc is recalling Bupropion Hydrochloride Extended-Release Tablets because they failed stability testing for dissolution specifications at 18 months.
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 FDA classified this recall as Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a failure in stability testing specifications rather than a direct contamination or acute safety hazard.
Plain-English summary
Actavis Inc is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 150mg. The recall was initiated because the product failed stability testing for dissolution specifications at 18 months.
The affected product is a prescription-only medication manufactured by Watson Laboratories, Inc. in Corona, CA. The recall covers 30-count, 90-count, and 500-count bottles (NDC 0591-3331-30, 0591-3331-19, and 0591-3331-05). The specific lots involved are 524099M, 524100A, and 521687A.
A total of 139,944 bottles were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 139,944
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 (3)
- Lots: 524099M
- 524100A
- 521687A
UPCs (1)
- 0305913331303
Distribution
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