Reported Aug 24, 2016 · Terminated
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), 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 68382-035-06) |
| 2 | 90-count bottles (NDC 68382-035-16), and |
| 3 | 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. |
- Lot codes and dates
Lot #: a) MS1217MS1218Exp.12/2017. Lot #: b) MS1215Exp.12/2017 Lot #: c) MR11150MR11151MR11854Exp. 10/2017MR11798MR11799MS1214Exp.11/2017
- Amount recalled
- N/A
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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