Azacitidine for Injection — Class III drug recall D-1349-2022
Terminated recall by Amerisource Health Services LLC, reported 2022-08-24, distributed nationwide. Subpotent Drug
| Recall number | D-1349-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2022-07-27 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 4,160 vials |
| Reason classes | potency |
| NDC | 68001-0313-56 |
| Lot numbers | FE22001A |
| Expiration dates | 2024-01 |
Product
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Reason for recall
Subpotent Drug
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-1349-2022. 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.