Could cause temporary or reversible harm; serious harm is unlikely.
Failed Impurities/Degradation Specifications
| Brand name | BUPROPION HYDROCHLORIDE |
| Generic name | BUPROPION HYDROCHLORIDE |
| Active ingredient(s) | BUPROPION HYDROCHLORIDE |
| Distributed by / for | American Health Packaging, Columbus, Ohio 43217 |
| Full product label | 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 |
| Recalling firm | Amerisource Health Services LLC |
| Distribution | Nationwide within the USA |
| Quantity | 1,416 cartons |
| Recall initiated | 2022-12-27 |
| Report date | 2023-02-22 |
| Recall completed | 2023-08-04 |
| Recall number | D-0328-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Columbus OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗