Reported Jul 31, 2024 · Terminated
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- 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
- byZydus Lifesciences Ltd. Ahmedabad, India; Dist
- byZydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Lot codes and dates
Lot #: a) M213175Exp. Date 09/2024b) M213176Exp. Date 09/2024
- Amount recalled
- a) 13,128 bottles; b) 252 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
This product could cause temporary or reversible health problems — stop using it.
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