FDA Drug recall D-1205-2018
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack
- FDA Drug
- Class III
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class III recall of MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack by Jubilant Cadista Pharmaceuticals, citing failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1205-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-27 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Reason
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Identifiers
| code_info | Lot # 17P0078, exp. date 12/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1205-2018%22
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