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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hikma Ganciclovir for Injection Recalled for Labeling Mix-up

Agency Publication Date: December 27, 2022
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Summary

Hikma Pharmaceuticals USA Inc. is recalling 13,760 vials of Ganciclovir for Injection, USP (500mg per vial). The recall was initiated because one vial within a 10-count carton was mislabeled as Cladribine Injection 10mg/mL. No incidents or injuries have been reported to date. This medication is typically administered in clinical settings like hospitals or infusion centers.

Risk

A labeling mix-up could cause a patient to receive Cladribine (a chemotherapy drug) instead of Ganciclovir (an antiviral medication), or vice versa. Administering the incorrect potent medication could lead to serious adverse health consequences or ineffective treatment of the intended condition.

What You Should Do

  1. The recalled product is Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton under NDC 0143-9299-01.
  2. Check the medication labels and cartons for lot number BQ0006 with an expiration date of 08/2023.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Ganciclovir for Injection, USP, 500mg per vial (10-count carton)
Variants: 500mg per vial
Lot Numbers:
BQ0006 (Exp 08/2023)
NDC:
0143-9299-01

Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany; Distributed by Hikma Berkeley Heights, NJ 07922

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91333
Status: Resolved
Manufacturer: Hikma Pharmaceuticals USA Inc.
Sold By: pharmacies; hospitals
Manufactured In: Germany, United States
Units Affected: 13,760 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.