MethylPREDNISolone TABLETS — Class III drug recall D-1605-2014
Terminated recall by Qualitest Pharmaceuticals, reported 2014-10-01, distributed nationwide. Subpotent; 6 month stability time point
| Recall number | D-1605-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2014-09-11 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2016-01-27 |
| Distributed | Nationwide (US) |
| Quantity | 159,913 tablets |
| Reason classes | potency, specification failure |
| NDC | 00603-4593, 00603-4593-15, 00603-4593-21 |
| Expiration dates | 2015-05 |
Product
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reason for recall
Subpotent; 6 month stability time point
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1605-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.