Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Lidocaine HCl Injection Recalled for Foreign Substance in Vials

Agency Publication Date: November 26, 2019

Summary

AuroMedics Pharma LLC has recalled approximately 111,850 vials of Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL). This prescription medication, which is typically used for local or regional anesthesia, was found to contain foreign material inside the vials. Consumers should check their supply for batch number CLC190049 with an expiration date of 02/2022. Because this is an injectable drug, the presence of any particulate matter can lead to serious health complications.

Risk

Injecting a product containing foreign material can lead to local inflammation, granuloma formation (small areas of inflammation), or more severe issues like the blockage of blood vessels, which can cause life-threatening clots in the lungs or other organs.

What You Should Do

Check your medical supplies for Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in cartons of 10 single-dose vials (NDC 55150-165-05).
Verify the batch number and expiration date on the vial or carton: look for Batch # CLC190049 with an expiration date of 02/2022.
If you identify an affected vial, stop using it immediately and do not administer the medication to any patient.
Contact your healthcare provider or pharmacist for guidance regarding alternative medications and return any unused product to the place of purchase for a refund.
Contact AuroMedics Pharma LLC for further instructions on how to handle the recalled product.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free

Model:

NDC 55150-165-05

Recall #: D-0573-2020

Lot Numbers:

CLC190049 (Exp 02/2022)

Date Ranges: Expiration 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84241

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: Hospitals; Clinics; Medical distributors

Manufactured In: United States

Units Affected: 111,850 vials

Distributed To: Nationwide

Agency Last Updated: December 5, 2019

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

Check your medical supplies for Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in cartons of 10 single-dose vials (NDC 55150-165-05).

Verify the batch number and expiration date on the vial or carton: look for Batch # CLC190049 with an expiration date of 02/2022.

If you identify an affected vial, stop using it immediately and do not administer the medication to any patient.

Contact your healthcare provider or pharmacist for guidance regarding alternative medications and return any unused product to the place of purchase for a refund.

Contact AuroMedics Pharma LLC for further instructions on how to handle the recalled product.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.