# FDA recall D-0122-2021

> **Shilpa Medicare Limited** · Class II · drug recall initiated 2020-12-08.

## 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

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0122-2021
- **Recalling firm:** Shilpa Medicare Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-08
- **Report date:** 2020-12-16
- **Termination date:** 2022-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Polepally, Jadcherla, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2021

## Citation

> AI Analytics. FDA recall D-0122-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0122-2021. Source: US FDA. Licensed CC0.

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