Ganciclovir Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0143-9299
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ganciclovir (NDC 0143-9299). A significant event, classified as Class II, was initiated on Dec 16, 2022 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Dec 16, 2022
Jan 04, 2023
13,760 vials
Recall Profile & Regulatory Data
Event ID
91333
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Dec 06, 2023
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
Batch or Lot Expiration Information
Lot# : BQ0006, Exp 08/2023
Affected Packages Involved in this Recall
0143-9299-01Product
0143-9299-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
