Recall: D-1449-2019

Class II - Potentially Harmful

Class IIClassification

2019-05-06Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

Product

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

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.