Recall: D-1448-2019

Class II - Potentially Harmful

Class IIClassification

2019-05-06Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

Product

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

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.