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-0508-2024

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief