Drug 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
D-0090-2023
Product summary
- Event
- Event 91333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,760 vials
- Official record key
drug-enforcement:D-0090-2023
Official wording
Reason: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Code information: Lot#: BQ0006, Exp 08/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled