ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hi...
FDA Recall #D-0173-2025 — Class II — December 19, 2024
Product Description
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
Reason for Recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Recalling Firm
Hikma Injectables USA Inc — Dayton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,800 syringes
Distribution
Nationwide in the USA
Code Information
Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated