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FDAFDA · Food and drugs·Recall number D-0174-2025

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

Published January 8, 2025 · Recall initiated: December 19, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hikma Injectables USA Inc
Distributor
Nationwide in the USA
Lot
Lot number: 243120003D, Use by Date: 03/11/2025
Risk classification
Class II
Area (FDA)
drug
Country
United States

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