Home / Recalls / Hikma Injectables USA Inc / D-0174-2025

D-0174-2025 Class II Terminated

Recalled by Hikma Injectables USA Inc — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
January 8, 2025
Initiation Date
December 19, 2024
Termination Date
November 12, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Reason for Recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Distribution Pattern

Nationwide in the USA

Code Information

Lot number: 243120003D, Use by Date: 03/11/2025

Other recalls by Hikma Injectables USA Inc

  • 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)
  • D-0508-2024 Class I — Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5m (April 29, 2024)