Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and
Recalled July 31, 2024 · FDA recall D-0617-2024 · Zydus Pharmaceuticals (USA)
Hazard
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. · FDA Class II
Units
a) 13,128 bottles; b) 252 bottles
Sold at
Nationwide within the United States
Description
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
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
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →