Drug product
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
D-0617-2024
Product summary
- Event
- Event 94850
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Official record key
drug-enforcement:D-0617-2024
Official wording
Reason: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Code information: Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-specification