Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx onl...
FDA Recall #D-0508-2024 — Class I — April 29, 2024
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
Reason for Recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Recalling Firm
Hikma Injectables USA Inc — Dayton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Distribution
CO, GA, PA, SD, WA
Code Information
Lot #: 240310003D, Exp 6/4/2024
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated