Azacitidine for Injection 100 mg/vial — Class II drug recall D-0122-2021
Terminated recall by Shilpa Medicare Limited, reported 2020-12-16, distributed nationwide. CGMP Deviations
| Recall number | D-0122-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shilpa Medicare Limited, Polepally, Jadcherla, N/A, India |
| Recall initiated | 2020-12-08 |
| Classified | 2020-12-09 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2022-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 35,931 vials |
| Reason classes | cgmp |
| NDC | 72485-0201, 72485-0201-01 |
| Lot numbers | 7S10115A, 7S10143A, 7S10182B, 7S10255A, 7S10256A, 7S10263A, 7T10028A, 7T10040A |
| Expiration dates | 2021-07-31, 2021-09-30, 2021-11-30, 2022-01-31 |
Product
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
Reason for recall
CGMP Deviations
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-0122-2021. 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.