Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx o...

FDA Recall #D-0480-2024 — Class III — April 30, 2024

Recall #D-0480-2024 Date: April 30, 2024 Classification: Class III Status: Completed

Product Description

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

Reason for Recall

Labeling: Wrong Barcode

Recalling Firm

Hikma Injectables USA Inc — Dayton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,895 bags

Distribution

Nationwide within the United States

Code Information

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

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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