Unlikely to cause harm — often a labeling or packaging issue.
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
| Distributed by / for | Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217 |
| NDC | 67767-142-30 |
| Full product label | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. |
| Recalling firm | Actavis Inc |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 15,132 bottles |
| Recall initiated | 2013-07-31 |
| Report date | 2013-08-14 |
| Recall completed | 2014-05-09 |
| Recall number | D-855-2013 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗