Hikma Pharmaceuticals USA Inc.: Drug Recall

Recall #D-0090-2023 · 12/16/2022

Class II: Risk

Recall Details

Recall Number: D-0090-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Hikma Pharmaceuticals USA Inc.
Status: Terminated
Date Initiated: 12/16/2022
Location: Cherry Hill, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,760 vials

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.

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

Other Recalls by Hikma Pharmaceuticals USA Inc.

Class II: Risk 07/22/2025

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class I: Dangerous 07/08/2024

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class II: Risk 03/12/2024

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class II: Risk 05/11/2023

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class II: Risk 07/11/2022

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

View all recalls by Hikma Pharmaceuticals USA Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.