Azacitidine for Injection 100mg/vial Lyophilized Powder — Class III drug recall D-1334-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-08-17, distributed in OH. Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Resul
| Recall number | D-1334-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-07-22 |
| Classified | 2022-08-11 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2023-04-12 |
| Distributed | OH |
| Quantity | 4,162 cartons |
| Reason classes | potency, specification failure |
| NDC | 68001-0313, 68001-0313-56 |
| Lot numbers | FE22001A |
| Expiration dates | 2024-01 |
Product
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Reason for recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
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-1334-2022. 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.