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Class II: temporary or reversible health riskTerminated

Nephron Sc S2 Racepinephrine Inhalation Solution Recall

S2 Racepinephrine Inhalation Solution, USP 2

Nephron Sc Inc · West Columbia, SC

Risk level
Class II
Reported by FDA
Feb 1, 2023
Recall ID
D-0176-2023
Check your lot numberHow we source this data

Summary

Nephron Sc recalled S2 Racepinephrine Inhalation Solution starting Jan 13, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0176-2023 on Feb 1, 2023. Reason: Short Fill. Status: Terminated.

Why it was recalled

Short Fill

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 126461, 126431 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-0176-2023
Classification
Class II
Status
Terminated
Recall initiated
Jan 13, 2023
FDA report date
Feb 1, 2023
Quantity
925,920 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Nephron Sc Inc

Original FDA data

Every field from FDA enforcement report D-0176-2023, 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 #: 126461, 126431 Exp. 04/30/2023
Postal code
29172-3025
Report date
Feb 1, 2023
Product type
Drugs
Recall number
D-0176-2023
Classification
Class II
Recalling firm
Nephron Sc Inc
Product quantity
925,920 vials
Termination date
Oct 11, 2024
Reason for recall
Short Fill
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0176-2023, published Feb 1, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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