April 2024 FDA Recall Drug by Hikma Injectables Usa Inc
D-0480-2024 - Labeling

This Class III drug recall was voluntarily initiated by Hikma Injectables Usa Inc on April 30, 2024 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0480-2024

Reason for Recall
Labeling: Wrong Barcode
Initiated
04-30-2024
Reported
05-08-2024
Quantity
1,895 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94528
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

Batch or Lot Expiration Information

Lot# : CH0324001, Exp. Date 3/4/2025