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Class II: temporary or reversible health riskTerminated

Hikma Pharmaceuticals Ganciclovir for Injection Recall

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only,…

Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ

Risk level
Class II
Reported by FDA
Jan 4, 2023
Recall ID
D-0090-2023
Check your lot numberHow we source this data

Summary

Hikma Pharmaceuticals recalled Ganciclovir for Injection starting Dec 16, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0090-2023 on Jan 4, 2023. Reason: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot#: BQ0006, Exp 08/2023

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0090-2023
Classification
Class II
Status
Terminated
Recall initiated
Dec 16, 2022
FDA report date
Jan 4, 2023
Quantity
13,760 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hikma Pharmaceuticals USA Inc.

Original FDA data

Every field from FDA enforcement report D-0090-2023, exactly as published.

Show all FDA fields
City
Cherry Hill
State
NJ
Status
Terminated
Country
United States
Event ID
91333
Address
2 Esterbrook Ln
Code information
Lot#: BQ0006, Exp 08/2023
Postal code
08003-4002
Report date
Jan 4, 2023
Product type
Drugs
Recall number
D-0090-2023
Classification
Class II
Recalling firm
Hikma Pharmaceuticals USA Inc.
Product quantity
13,760 vials
Termination date
Dec 6, 2023
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
USA Nationwide
Recall initiation date
Dec 16, 2022
Center classification date
Dec 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0090-2023, published Jan 4, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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