Ketamine inj 50 mg per recalled over sterility concerns

Recall date

December 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hikma Injectables USA Inc recalls 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 In…

Recall number

D-0173-2025

FDA classification

Class II

Brand / firm

Hikma Injectables USA Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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