# FDA recall D-0165-2021

> **CIPLA** · Class II · drug recall initiated 2020-12-14.

## 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.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0165-2021
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-14
- **Report date:** 2020-12-23
- **Termination date:** 2022-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2021

## Citation

> AI Analytics. FDA recall D-0165-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0165-2021. Source: US FDA. Licensed CC0.

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