April 2024 FDA Recall Drug by Hikma Injectables Usa Inc
D-0508-2024 - Labeling

This Class I drug recall was voluntarily initiated by Hikma Injectables Usa Inc on April 29, 2024 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CO, GA, PA, SD, WA and the recall is currently completed.

Recall Number: D-0508-2024

Reason for Recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Initiated
04-29-2024
Reported
05-29-2024
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94522
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Injectables USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, GA, PA, SD, WA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 240310003D, Exp 6/4/2024