FDA-Drug2025-01-08Class II

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

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
Manufactured in
36 Stults Rd, Dayton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2025

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