Why it was recalled
Short Fill
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 126451 Exp. 04/30/2023
Where it was sold
Nationwide within the United States including Puerto Rico. Guatamala
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0175-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 13, 2023
- FDA report date
- Feb 1, 2023
- Quantity
- 387,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sc Inc
Original FDA data
Every field from FDA enforcement report D-0175-2023, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 91451
- Address
- 4500 12th Street Ext
- Code information
- Lot #: 126451 Exp. 04/30/2023
- Postal code
- 29172-3025
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0175-2023
- Classification
- Class II
- Recalling firm
- Nephron Sc Inc
- Product quantity
- 387,000 vials
- Termination date
- Oct 11, 2024
- Reason for recall
- Short Fill
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States including Puerto Rico. Guatamala
- Recall initiation date
- Jan 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2023