Medications & Supplements/Prescription Drugs

AuroMedics Nicardipine Hydrochloride Injection Recalled for Impurities

Agency Publication Date: March 19, 2024

Summary

Eugia US LLC is recalling 379,860 vials of Nicardipine Hydrochloride Injection (generic Nicardipine), which is distributed by AuroMedics Pharma LLC. This medication, used for the short-term treatment of high blood pressure, was found to have organic impurities that exceed required safety specifications. The recall affects several batches distributed nationwide within the United States.

Risk

Using a medication that contains impurities or degradation products above specified limits could potentially lead to adverse health effects or cause the drug to be less effective in managing blood pressure.

What You Should Do

This recall affects Nicardipine Hydrochloride Injection (2.5mg/mL) sold in 10 mL vials under the AuroMedics Pharma LLC brand with NDC 55150-183-10 and NDC 55150-183-11.
Check for lot numbers 3NC23002 (Exp 7/24), 3NC22013 (Exp 2/24), 3NC22014 (Exp 2/24), 3NC22015 (Exp 2/24), 3NC22016 (Exp 2/24), 3NC22017 (Exp 2/24), 3NC22018 (Exp 2/24), 3NC22020 (Exp 3/24), and 3NC22019 (Exp 2/24).
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Nicardipine Hydrochloride Injection (25mg per 10mL)

Variants: 2.5mg/mL, 10mL Vial, Rx only

Lot Numbers:

3NC23002 (Exp. Date 7/24)

3NC22013 (Exp. Date 2/24)

3NC22014 (Exp. Date 2/24)

3NC22015 (Exp. Date 2/24)

3NC22016 (Exp. Date 2/24)

3NC22017 (Exp. Date 2/24)

3NC22018 (Exp. Date 2/24)

3NC22020 (Exp. Date 3/24)

NDC:

55150-183-10

Distributed by AuroMedics Pharma LLC

Product: Nicardipine Hydrochloride Injection, USP (25mg per 10mL)

Variants: 2.5 mg/mL, 10 mL vials

Lot Numbers:

3NC22019 (Exp. Date 2/24)

NDC:

55150-183-11

Distributed by AuroMedics Pharma LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94073

Status: Active

Manufacturer: Eugia US LLC

Sold By: AuroMedics Pharma LLC

Manufactured In: United States

Units Affected: 2 products (335,940 vials; 43,920 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 Nicardipine Hydrochloride Injection (2.5mg/mL) sold in 10 mL vials under the AuroMedics Pharma LLC brand with NDC 55150-183-10 and NDC 55150-183-11.

Check for lot numbers 3NC23002 (Exp 7/24), 3NC22013 (Exp 2/24), 3NC22014 (Exp 2/24), 3NC22015 (Exp 2/24), 3NC22016 (Exp 2/24), 3NC22017 (Exp 2/24), 3NC22018 (Exp 2/24), 3NC22020 (Exp 3/24), and 3NC22019 (Exp 2/24).

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

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

Affected Products

Product: Nicardipine Hydrochloride Injection (25mg per 10mL)

Variants: 2.5mg/mL, 10mL Vial, Rx only

Lot Numbers:

3NC23002 (Exp. Date 7/24)

3NC22013 (Exp. Date 2/24)

3NC22014 (Exp. Date 2/24)

3NC22015 (Exp. Date 2/24)

3NC22016 (Exp. Date 2/24)

3NC22017 (Exp. Date 2/24)

3NC22018 (Exp. Date 2/24)

3NC22020 (Exp. Date 3/24)

NDC:

55150-183-10

Distributed by AuroMedics Pharma LLC

Product: Nicardipine Hydrochloride Injection, USP (25mg per 10mL)

Variants: 2.5 mg/mL, 10 mL vials

Lot Numbers:

3NC22019 (Exp. Date 2/24)

NDC:

55150-183-11

Distributed by AuroMedics Pharma LLC