# FDA recall D-0309-2021

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2021-03-04.

## Product

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

## Reason for recall

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0309-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-04
- **Report date:** 2021-03-24
- **Termination date:** 2022-05-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0309-2021

## Citation

> AI Analytics. FDA recall D-0309-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/D-0309-2021. Source: US FDA. Licensed CC0.

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