Drug product
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
D-0310-2025
Product summary
- Event
- Event 96553
- Status
- Completed
- Classification
- Class II
- Quantity
- 13,128 100-Count Bottles
- Official record key
drug-enforcement:D-0310-2025
Official wording
Reason: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Code information: Lot #: M314265, Exp.: 31 October 2025.
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance