Status
Terminated
Drug Enforcement D-0328-2023
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
February 22, 2023
Termination Date
August 4, 2023
Product Information
- Product description
- 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
- Product quantity
- 1,416 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the USA
Location & Firm
- Recalling firm
- Amerisource Health Services LLC
- Address
-
2550 John Glenn Ave Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0328-2023
- Event ID
- 91609
- Recall initiation date
- December 27, 2022
- Center classification date
- February 16, 2023
- Code info
- Lot #: 1003837, Exp. Date 01/31/2023
- More code info
- —