Medications & Supplements/Over-the-Counter

Asthmanefrin and S2 Racepinephrine Recalled for Short Fill

Agency Publication Date: January 23, 2023

Summary

Nephron Sc Inc has voluntarily recalled 1,312,920 vials of Asthmanefrin and S2 Racepinephrine Inhalation Solution (racepinephrine) because the vials may contain less medication than the labeled amount, known as a "short fill." This recall affects 30-count packages of sterile vials individually wrapped in foil pouches sold nationwide through pharmacies. No incidents or injuries have been reported to date in connection with this issue.

Risk

A short-filled vial may result in a patient receiving an insufficient dose of the bronchodilator medication. This could fail to adequately relieve asthma symptoms during use, potentially leading to a delay in treatment for a respiratory event.

What You Should Do

This recall affects Asthmanefrin Racepinephrine (racephedrine, USP 11.25) and S2 Racepinephrine (USP 2.25%) Inhalation Solutions sold in 30-count boxes of 0.5 mL sterile vials.
Check your medication for Asthmanefrin (NDC 0487-2784-01, UPC 304872784014) with lot number 126451, or S2 Racepinephrine (NDC 0487-5901-99, UPC 304875901999) with lot numbers 126461 or 126431. All affected lots have an expiration date of 04/30/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25)

Variants: 30x0.5 mL Sterile Vials, Foil pouch

UPC Codes:

304872784014

Lot Numbers:

126451 (Exp. 04/30/2023)

NDC:

0487-2784-01

Quantity: 387,000 vials

Product: S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator

Variants: 30x0.5 mL Sterile Unit-of-Use Vials, Foil pouch

UPC Codes:

304875901999

Lot Numbers:

126461 (Exp. 04/30/2023)

126431 (Exp. 04/30/2023)

NDC:

0487-5901-99

Quantity: 925,920 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91451

Status: Resolved

Manufacturer: Nephron Sc Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (387,000 vials; 925,920 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Asthmanefrin Racepinephrine (racephedrine, USP 11.25) and S2 Racepinephrine (USP 2.25%) Inhalation Solutions sold in 30-count boxes of 0.5 mL sterile vials.

Check your medication for Asthmanefrin (NDC 0487-2784-01, UPC 304872784014) with lot number 126451, or S2 Racepinephrine (NDC 0487-5901-99, UPC 304875901999) with lot numbers 126461 or 126431. All affected lots have an expiration date of 04/30/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25)

Variants: 30x0.5 mL Sterile Vials, Foil pouch

UPC Codes:

304872784014

Lot Numbers:

126451 (Exp. 04/30/2023)

NDC:

0487-2784-01

Quantity: 387,000 vials

Product: S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator

Variants: 30x0.5 mL Sterile Unit-of-Use Vials, Foil pouch

UPC Codes:

304875901999

Lot Numbers:

126461 (Exp. 04/30/2023)

126431 (Exp. 04/30/2023)

NDC:

0487-5901-99

Quantity: 925,920 vials