D-1205-2018 Class III Terminated
FDA drug recall D-1205-2018 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on August 27, 2018 and is designated Class III. Reason for recall: Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay. The recall status is terminated (terminated October 8, 2019). Affected quantity: 89,722 blister pack.
Recall Details
- Product Type
- Drugs
- Report Date
- September 26, 2018
- Initiation Date
- August 27, 2018
- Termination Date
- October 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,722 blister pack
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.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 17P0078, exp. date 12/2018