← FDA ENFORCEMENT
D-0480-2024Class III

Hikma Injectables USA Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Hikma Injectables USA Inc
Product type
Drug
Status
Completed
Report date
2024-05-08
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
1,895 bags
Initiated by
Voluntary: Firm initiated
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

Data: U.S. FDA. 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. Open the enforcement explorer →