# FDA recall D-0090-2023

> **Hikma Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2022-12-16.

## Product

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01

## Reason for recall

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0090-2023
- **Recalling firm:** Hikma Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-16
- **Report date:** 2023-01-04
- **Termination date:** 2023-12-06

- **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-0090-2023

## Citation

> AI Analytics. FDA recall D-0090-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0090-2023. Source: US FDA. Licensed CC0.

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