Recalls / Class II
Class IID-0176-2023
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
- Brand name
- S2
- Generic name
- Racepinephrine Hydrochloride
- Active ingredient
- Racepinephrine Hydrochloride
- Route
- Respiratory (inhalation)
- NDC
- 0487-5901
- FDA application
- M012
- Affected lot / code info
- Lot #: 126461, 126431 Exp. 04/30/2023
Why it was recalled
Short Fill
Recalling firm
- Firm
- Nephron Sc Inc
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 925,920 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-0176-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.