FDA recall D-0328-2023

Amerisource Health Services LLC · Class II · drug

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the USA

Key facts

Status
Terminated
Initiation date
2022-12-27
Report date
2023-02-22
Termination date
2023-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0328-2023