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
Recall Number: D-1449-2019
Firm: Zydus Pharmaceuticals USA Inc
Classification: Class II
Status: Terminated
Report Date: 20190626
Initiation Date: 20190506
Termination Date: 20210916
Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product Description
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