PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 26, 2018 Initiated: August 27, 2018 #D-1205-2018

Product Description

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.

Details

Units Affected
89,722 blister pack
Distribution
Product was distributed throughout the United States.
Location
Salisbury, MD

Frequently Asked Questions

What product was recalled?
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 89,722 blister pack.
Why was this product recalled?
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 26, 2018. Severity: Low. Recall number: D-1205-2018.