Recalls / Class II
Class IID-0590-2024
Product
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 60687-782, 60687-793
- FDA application
- ANDA090693
- Affected lot / code info
- Lot 1017343, Exp. 12/31/2025
Why it was recalled
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2,484 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-06-24
- FDA classified
- 2024-07-08
- Posted by FDA
- 2024-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0590-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.