phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables...
FDA Recall #D-0174-2025 — Class II — December 19, 2024
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
Reason for Recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Recalling Firm
Hikma Injectables USA Inc — Dayton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
Nationwide in the USA
Code Information
Lot number: 243120003D, Use by Date: 03/11/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated