Class II
Terminated
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
This recall has been terminated (originally issued July 31, 2024).
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- June 21, 2024
- Posted
- July 31, 2024
- Recall Number
- D-0617-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
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