Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 6838…

Recall date

July 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1461-2016

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.