# FDA recall D-0820-2021

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2021-08-27.

## Product

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0820-2021
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-27
- **Report date:** 2021-09-29
- **Termination date:** 2023-10-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2021

## Citation

> AI Analytics. FDA recall D-0820-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0820-2021. Source: US FDA. Licensed CC0.

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