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Class II · ModerateRecall completed

Ganciclovir

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: BQ0006, Exp 08/2023
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Pharmaceuticals USA Inc.
Brand nameGANCICLOVIR
Generic nameGANCICLOVIR SODIUM
Active ingredient(s)GANCICLOVIR SODIUM
Distributed by / forHikma Berkeley Heights, NJ 07922
NDC0143-9299-01
Show the full FDA record
Full product labelGanciclovir 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
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionUSA Nationwide
Quantity13,760 vials
Recall initiated2022-12-16
Report date2023-01-04
Recall completed2023-12-06
Recall numberD-0090-2023
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.