Drug 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.
D-1461-2016
Product summary
- Event
- Event 74753
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1461-2016
Official wording
Reason: Failed Dissolution Specifications: out of specification dissolution results in retained samples
Code information: Lot #: a) MS1217, MS1218 , Exp.12/2017. Lot #: b) MS1215, Exp.12/2017 Lot #: c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification