Reported Jun 26, 2019 · Terminated

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus…

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?

  • MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only
  • Made in India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1M800150 Feb-20
2M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20
3M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20
4M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20
5M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20
6M816286, M816288, M816289, M816290, M817612, EXP OCT-20
7M817613, M817614, M817615, M817616, M818315, EXP Nov-20
8M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21
Amount recalled
N/A

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 16, 2021 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.