FDAFDA · Food and drugs·Recall number D-1460-2016
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.
Published August 24, 2016 · Recall initiated: July 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: out of specification dissolution results in retained samples
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide
- UPC
- 0368382034106
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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