FDA recall D-0176-2023

Nephron Sc Inc · Class II · drug

Product

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

Reason for recall

Short Fill

Distribution

Nationwide within the United States including Puerto Rico. Guatamala

Key facts

Status
Terminated
Initiation date
2023-01-13
Report date
2023-02-01
Termination date
2024-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2023