Pyrazinamide — Class II drug recall D-0578-2023
Ongoing recall by RemedyRepack Inc., reported 2023-05-24. CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the ide
| Recall number | D-0578-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-05-16 |
| Reported by FDA | 2023-05-24 |
| Reason classes | potency, cgmp |
| NDC | 61748-0012-01, 70518-2534-00, 70518-2534-01 |
| Expiration dates | 2023-08-17, 2024-02-28 |
Product
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
Reason for recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
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-0578-2023. 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.