Drug product
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
D-1458-2016
Product summary
- Event
- Event 74847
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65,401 bottles
- Official record key
drug-enforcement:D-1458-2016
Official wording
Reason: Failed Dissolution Specifications: Out-of-specification results in retained sample.
Code information: Lot #: a) GS011931, Exp 10/2017; GS011932, Exp 11/2017 b) GS010773, GS011242, 09/2017; GS011061, GS011315, GS011357, GS011585, GS011586, GS011588, GS011591, Exp 10/2017; GS011933, Exp 11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out-of-specification