Drug product
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
D-1459-2016
Product summary
- Event
- Event 74847
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,631 bottles
- Official record key
drug-enforcement:D-1459-2016
Official wording
Reason: Failed Dissolution Specifications: Out-of-specification results in retained sample.
Code information: Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out-of-specification