Hikma Injectables USA Inc: Drug Recall

Recall #D-0480-2024 · 04/30/2024

Class III: Low Risk

Recall Details

Recall Number: D-0480-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Hikma Injectables USA Inc
Status: Completed
Date Initiated: 04/30/2024
Location: Dayton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,895 bags

Reason for Recall

Labeling: Wrong Barcode

Product Description

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

Distribution Pattern

Nationwide within the United States

Other Recalls by Hikma Injectables USA Inc

Class II: Risk 12/19/2024

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II: Risk 12/19/2024

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class I: Dangerous 04/29/2024

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

View all recalls by Hikma Injectables 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.