FDA recall D-1205-2018

Product

MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03

Reason for recall

Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-08-27

Report date

2018-09-26

Termination date

2019-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1205-2018