Reported Jan 4, 2023 · Terminated

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE…

Hikma Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002

Is this the product you have?

  • Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd
  • byTHYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
Lot codes and dates
    • Lot#: BQ0006
    • Exp 08/2023
Amount recalled
13,760 vials

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 6, 2023 · Data as of Sep 19, 3:29 PM UTC

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