Drug 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
Lots and codes
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
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- N/A
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 19, 2016
- Terminated
- September 21, 2020
Related products
- Venlafaxine Hydrochloride – drug information
- NDC 68382-035 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 75 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-034 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 37.5 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-036 Venlafaxine hydrochloride · Venlafaxine Hydrochloride 150 mg/1 · Zydus Pharmaceuticals USA Inc.