Reported Aug 24, 2016 · Terminated
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC…
Zydus Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottles (NDC 68382-036-06) |
| 2 | 90-count bottles (NDC 68382-036-16), and |
| 3 | 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. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot # 2 MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot # 3 MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017. - Amount recalled
- 223,776 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: out of specification dissolution results in retained samples
This product could cause temporary or reversible health problems — stop using it.
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