D-0090-2023 Class II Terminated
FDA drug recall D-0090-2023 was initiated by Hikma Pharmaceuticals USA Inc. on December 16, 2022 and is designated Class II. 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. The recall status is terminated (terminated December 6, 2023). Affected quantity: 13,760 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 4, 2023
- Initiation Date
- December 16, 2022
- Termination Date
- December 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,760 vials
Product Description
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.
Distribution Pattern
USA Nationwide
Code Information
Lot#: BQ0006, Exp 08/2023