FDA recall D-0508-2024

Product

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

Reason for recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Distribution

CO, GA, PA, SD, WA

Key facts

Status

Completed

Initiation date

2024-04-29

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0508-2024