MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmace...
FDA Recall #D-1205-2018 — Class III — August 27, 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.
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
89,722 blister pack
Distribution
Product was distributed throughout the United States.
Code Information
Lot # 17P0078, exp. date 12/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated