Azacitidine for Injection 100 mg/vial For Subcutaneous and… — Class II drug recall D-0165-2021
Terminated recall by CIPLA, reported 2020-12-23, distributed nationwide. cGMP deviations: Vials may not be sealed correctly affecting sterility.
| Recall number | D-0165-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2020-12-14 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2022-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,151 vials |
| Reason classes | sterility, cgmp |
| NDC | 69097-0805-40 |
| Lot numbers | 7S10182A |
Product
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
Reason for recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
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-0165-2021. 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.