FDA Drug Recalls

Recalls / Class II

Class IID-0175-2023

Product

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4

Affected lot / code info
Lot #: 126451 Exp. 04/30/2023

Why it was recalled

Short Fill

Recalling firm

Firm
Nephron Sc Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025

Distribution

Quantity
387,000 vials
Distribution pattern
Nationwide within the United States including Puerto Rico. Guatamala

Timeline

Recall initiated
2023-01-13
FDA classified
2023-01-23
Posted by FDA
2023-02-01
Terminated
2024-10-11
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0175-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls