FDA-Drug2023-01-04Class II
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
Hikma Pharmaceuticals USA Inc.
Hazard
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Sold states
USA Nationwide
Affected count
13,760 vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0090-2023Don't want to check this manually?
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