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

FDA recall notice · announced September 26, 2018 · Jubilant Cadista Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Product was distributed throughout the United States.
Lot/code information: Lot # 17P0078, exp. date 12/2018
Quantity: 89,722 blister pack
Status: Terminated
Products in this recall event:
- MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03 (D-1205-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.