FDA-Drug2024-07-31Class II
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
Zydus Pharmaceuticals (USA) Inc
Hazard
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Sold states
Nationwide within the United States
Affected count
a) 13,128 bottles; b) 252 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2024Don't want to check this manually?
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