FDA recall D-1461-2016

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 for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-07-19

Report date

2016-08-24

Termination date

2020-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1461-2016