Unlikely to cause harm — often a labeling or packaging issue.
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
| Distributed by / for | Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217 |
| NDC | 67767-142-30 |
| Full product label | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217 |
| Recalling firm | Actavis Pharmaceuticals |
| Distribution | Nationwide |
| Quantity | 14,856 bottles |
| Recall initiated | 2013-01-04 |
| Report date | 2013-03-06 |
| Recall completed | 2014-01-13 |
| Recall number | D-175-2013 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Morristown NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗