Drug product
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
D-175-2013
Product summary
- Event
- Event 64317
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,856 bottles
- Official record key
drug-enforcement:D-175-2013
Official wording
Reason: Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Code information: Lot CB1D05A,
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications