Drug recall D-0617-2024
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
Reason for recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Lots and codes
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 21, 2024
- Terminated
- August 6, 2025
Related products
- Venlafaxine Hydrochloride – drug information
- NDC 68382-035 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 75 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-034 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 37.5 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-036 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 150 mg/1 · Zydus Pharmaceuticals USA Inc.