Drug product
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
D-1205-2018
Product summary
- Event
- Event 80951
- Status
- Terminated
- Classification
- Class III
- Quantity
- 89,722 blister pack
- Official record key
drug-enforcement:D-1205-2018
Official wording
Reason: Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Code information: Lot # 17P0078, exp. date 12/2018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Potency or specification failure
out-of-specification