Hikma Injectables USA Inc: Drug Recall

Recall #D-0174-2025 · 12/19/2024

Class II: Risk

Recall Details

Recall Number: D-0174-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Hikma Injectables USA Inc
Status: Terminated
Date Initiated: 12/19/2024
Location: Dayton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Product Description

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Distribution Pattern

Nationwide in the USA

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 III: Low Risk 04/30/2024

Labeling: Wrong Barcode
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.