PlainRecalls
FDA Drug Moderate Class II Terminated

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Reported: June 26, 2019 Initiated: May 6, 2019 #D-1448-2019

Product Description

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Reason for Recall

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

Details

Units Affected
34521 100-count bottles
Distribution
Nationwide in the USA
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 34521 100-count bottles.
Why was this product recalled?
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 26, 2019. Severity: Moderate. Recall number: D-1448-2019.