FDA-Drug2016-08-24Class II
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Zydus Pharmaceuticals USA Inc
Hazard
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Sold states
Nationwide
Affected count
223,776 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1460-2016Don't want to check this manually?
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