Drug product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
D-1501-2016
Product summary
- Event
- Event 75030
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2626 bottles
- Official record key
drug-enforcement:D-1501-2016
Official wording
Reason: Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Code information: Lot #: MS1509, Exp 12/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification