FDA recall D-0173-2025

Hikma Injectables USA Inc · Class II · drug

Product

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2024-12-19
Report date
2025-01-08
Termination date
2025-11-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2025