Recall: D-1461-2016

Class II - Potentially Harmful

Class IIClassification

2016-07-19Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

Product

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.

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.