Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, LLC: Lidocaine HCl Syringes Recalled for Foreign Material Contamination

Agency Publication Date: December 10, 2019

Summary

SCA Pharmaceuticals, LLC has recalled 1,363 syringes of Lidocaine HCl 2% (5 mL), a prescription local anesthetic. The recall was initiated after foreign material was discovered inside the vial during manufacturing. Using an injectable medication that contains unidentified particles can lead to serious health complications, such as inflammation or infection at the injection site. These products were distributed to healthcare facilities nationwide.

Risk

The presence of a foreign substance in a sterile injectable drug poses a significant health risk. If injected, the particles could cause local tissue irritation, blockage of blood vessels, or a systemic immune response.

What You Should Do

Identify your product by checking the label for Lidocaine HCl 2% 5 mL Syringes from SCA Pharmaceuticals.
Check the packaging for NDC 70004-0723-09 and lot numbers 1219012595 (with date 29-Dec-19) or 1219012647 (with date 01-Jan-20).
If you are a healthcare provider, immediately quarantine any syringes from these specific lots and do not administer them to patients.
If you are a patient and believe you have received this medication, contact your healthcare provider or pharmacist immediately to discuss potential health concerns and arrange for replacement medication.
Return any unused product to the place of purchase for a refund and contact SCA Pharmaceuticals for further instructions on the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund and medical consultation.

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 2% 5 mL, Syringe, Rx Only

Model:

NDC 70004-0723-09

D-0620-2020

Lot Numbers:

1219012595 (29-Dec-19)

1219012647 (01-Jan-20)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84326

Status: Resolved

Manufacturer: SCA Pharmaceuticals, LLC

Sold By: Hospitals; Healthcare facilities; Pharmacies

Manufactured In: United States

Units Affected: 1363 syringes

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

Identify your product by checking the label for Lidocaine HCl 2% 5 mL Syringes from SCA Pharmaceuticals.

Check the packaging for NDC 70004-0723-09 and lot numbers 1219012595 (with date 29-Dec-19) or 1219012647 (with date 01-Jan-20).

If you are a healthcare provider, immediately quarantine any syringes from these specific lots and do not administer them to patients.

If you are a patient and believe you have received this medication, contact your healthcare provider or pharmacist immediately to discuss potential health concerns and arrange for replacement medication.

Return any unused product to the place of purchase for a refund and contact SCA Pharmaceuticals for further instructions on the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.