Recalls / Class II
Class IID-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
- Brand name
- Venlafaxine Hydrochloride
- Generic name
- Venlafaxine Hydrochloride
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 68382-034, 68382-035, 68382-036
- FDA application
- ANDA090174
- Affected lot / code info
- Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-06-21
- FDA classified
- 2024-07-23
- Posted by FDA
- 2024-07-31
- Terminated
- 2025-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0617-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.