FDAFDA · Food and drugs·Recall number D-0090-2023
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
Published January 4, 2023 · Recall initiated: December 16, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- GANCICLOVIR
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- USA Nationwide
- Lot
- Lot#: BQ0006, Exp 08/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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