Drug recall D-1460-2016
Product
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), 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) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot #: b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017.
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 223,776 bottles
- 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.