FDA Recall Terminated Historical recordClass II
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
- Published
- August 24, 2016
- Distribution
- Nationwide
