D-0480-2024Class III

Hikma Injectables USA Inc

Recalling firm

Product type

Drug

Status

Completed

Report date

2024-05-08

Distribution

Nationwide within the United States

Firm state

Product quantity

1,895 bags

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Labeling: Wrong Barcode

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.