Recalls / Class II
Class IID-0328-2023
Product
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 60687-340, 60687-351
- FDA application
- ANDA076143
- Affected lot / code info
- Lot #: 1003837, Exp. Date 01/31/2023
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 1,416 cartons
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2022-12-27
- FDA classified
- 2023-02-16
- Posted by FDA
- 2023-02-22
- Terminated
- 2023-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0328-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.