Hikma Pharmaceuticals recalls Ganciclovir injection vials due to mislabeling with Cladribine. Affected units may contain incorrect labeling that could lead to medication errors.
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Hikma Pharmaceuticals is recalling Ganciclovir injection vials that were mislabeled as Cladribine. This mix-up could cause serious medication errors if the wrong drug is used.
The vials were mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500mg. This mix-up could lead to using the wrong medication if the label is not checked carefully.
Patients prescribed Ganciclovir injection by a doctor are affected. Those using the product without medical supervision are not at risk.
Check for vials labeled 'Cladribine Injection 10mg/mL' in a 10-count carton. The product was manufactured by Thymoorgan Pharma in Germany and distributed by Hikma in the US.
Ensure the label reads 'Ganciclovir Injection, USP, 500mg per vial' not 'Cladribine Injection 10mg/mL'.
The product is safe if labeled correctly. Mislabeling could cause medication errors, so check the label before use.
Look for vials labeled 'Cladribine Injection 10mg/mL' in a 10-count carton. The product was manufactured by Thymoorgan Pharma in Germany and distributed by Hikma in the US.
Check the label carefully to ensure it reads 'Ganciclovir Injection, USP, 500mg per vial'. If mislabeled, contact your doctor.
We’ve drafted a message you can send Hikma to request your refund or repair — edit it as you like.
Subject: Recall D-0090-2023 — Hikma Hikma Hello, I own a Hikma that is covered by recall D-0090-2023 from Hikma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
