FDAClass IIISeptember 26, 2018

MethylPREDNISolone Tablets recall

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

Why was MethylPREDNISolone Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 17P0078, exp. date 12/2018

Product
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
89,722 blister pack
Distribution
Product was distributed throughout the United States.
Recall date
September 26, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls