D-0617-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2024
- Initiation Date
- June 21, 2024
- Termination Date
- August 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 13,128 bottles; b) 252 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024