Drug product
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
D-1043-2014
Product summary
- Firm
- Actavis Inc
- Event
- Event 66961
- Status
- Terminated
- Classification
- Class III
- Quantity
- 139,944 bottles
- Official record key
drug-enforcement:D-1043-2014
Official wording
Reason: Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Code information: Lots: 524099M, 524100A, 521687A
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications