# FDA recall D-0661-2021

> **Teva Pharmaceuticals USA** · Class I · drug recall initiated 2021-06-18.

## Product

Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71

## Reason for recall

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0661-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-18
- **Report date:** 2021-07-14
- **Termination date:** 2022-04-04

- **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-0661-2021

## Citation

> AI Analytics. FDA recall D-0661-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0661-2021. Source: US FDA. Licensed CC0.

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