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#: BQ0006Exp 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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