Hikma Injectables USA Inc: Drug Recall

Recall #D-0508-2024 · 04/29/2024

Class I: Dangerous

Recall Details

Recall Number: D-0508-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Hikma Injectables USA Inc
Status: Completed
Date Initiated: 04/29/2024
Location: Dayton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

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

Product Description

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Distribution Pattern

CO, GA, PA, SD, WA

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 III: Low Risk 04/30/2024

Labeling: Wrong Barcode

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.