Home / Recalls / Hikma Injectables USA Inc / D-0508-2024

D-0508-2024 Class I

Recalled by Hikma Injectables USA Inc — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
May 29, 2024
Initiation Date
April 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Reason for Recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Distribution Pattern

CO, GA, PA, SD, WA

Code Information

Lot #: 240310003D, Exp 6/4/2024

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-0480-2024 Class III — Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in (April 30, 2024)