FDA-Drug2024-05-29Class I
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Hikma Injectables USA Inc
Hazard
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Sold states
CO, GA, PA, SD, WA
Manufactured in
36 Stults Rd, Dayton, NJ, United States
Products
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0508-2024Don't want to check this manually?
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