D-0328-2023 Class II Terminated
FDA drug recall D-0328-2023 was initiated by Amerisource Health Services LLC on Dec 27, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 4, 2023). Affected quantity: 1,416 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 22, 2023
- Initiation Date
- Dec 27, 2022
- Termination Date
- Aug 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,416 cartons
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: 1003837, Exp. Date 01/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0328-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026