Drug recall D-0090-2023

Class II Terminated reported Jan 4, 2023

Product

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

Reason for recall

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

Lots and codes

Lot#: BQ0006, Exp 08/2023

Recall details

Recalling firm
Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
Quantity
13,760 vials
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2022
Terminated
December 6, 2023

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