FDA-Drug2025-01-08Class II
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
Hikma Injectables USA Inc
Hazard
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Sold states
Nationwide in the USA
Affected count
1,800 syringes
Manufactured in
36 Stults Rd, Dayton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2025Don't want to check this manually?
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