Drug product
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.
D-855-2013
Product summary
- Firm
- Actavis Inc
- Event
- Event 65881
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,132 bottles
- Official record key
drug-enforcement:D-855-2013
Official wording
Reason: Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Code information: Lot #: CG2D18A, Exp 06/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications