Hikma Pharmaceuticals USA Inc.: Drug Recall

Recall #D-0392-2024 · 03/12/2024

Class II: Risk

Recall Details

Recall Number: D-0392-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Hikma Pharmaceuticals USA Inc.
Status: Ongoing
Date Initiated: 03/12/2024
Location: Cherry Hill, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,644 ampuls

Reason for Recall

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Product Description

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

Distribution Pattern

Nationwide within the United States

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 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 12/16/2022

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