Hikma Pharmaceuticals USA Inc.: Drug Recall

Recall #D-0771-2021 · 08/05/2021

Class III: Low Risk

Recall Details

Recall Number: D-0771-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Hikma Pharmaceuticals USA Inc.
Status: Terminated
Date Initiated: 08/05/2021
Location: Cherry Hill, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,152 vials

Reason for Recall

Labeling: Not elsewhere classified: Mislabeling

Product Description

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

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 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.

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.