FDA recall D-1453-2019

Zydus Pharmaceuticals USA Inc · Class II · drug

Product

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-05-06
Report date: 2019-06-26
Termination date: 2021-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1453-2019