Drug product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
D-892-2013
Product summary
- Event
- Event 65457
- Status
- Terminated
- Classification
- Class III
- Quantity
- 389 cartons
- Official record key
drug-enforcement:D-892-2013
Official wording
Reason: Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Code information: The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification