# FDA recall D-0771-2021

> **Hikma Pharmaceuticals USA Inc.** · Class III · drug recall initiated 2021-08-05.

## Product

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

## Reason for recall

Labeling: Not elsewhere classified: Mislabeling

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0771-2021
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-05
- **Report date:** 2021-09-01
- **Termination date:** 2023-06-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0771-2021

## Citation

> AI Analytics. FDA recall D-0771-2021. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/D-0771-2021. Source: US FDA. Licensed CC0.

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