Home / Recalls / Hikma Injectables USA Inc / D-0480-2024

D-0480-2024 Class III

Recalled by Hikma Injectables USA Inc — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
May 8, 2024
Initiation Date
April 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,895 bags

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

Distribution Pattern

Nationwide within the United States

Code Information

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

Other recalls by Hikma Injectables USA Inc

  • D-0174-2025 Class II — phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, (December 19, 2024)
  • D-0173-2025 Class II — ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For (December 19, 2024)
  • D-0508-2024 Class I — Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5m (April 29, 2024)