Medications & Supplements/Prescription Drugs

Septodont Inc.: Articaine DENTAL Anesthetic Recalled for Carton Mislabeling

Agency Publication Date: May 20, 2019

Summary

Approximately 240 cartons of Articaine DENTAL (articaine hydrochloride 4% and epinephrine 1:100,000) are being recalled because the outer packaging is mislabeled. The printed carton contains conflicting information, listing both 2% Xylocaine (lidocaine) and Articadent (articaine), which are two different types of dental anesthetics. While the individual cartridges inside the box are labeled correctly as Articadent, the confusing box text could lead to medication errors during dental procedures. These products were distributed nationwide in the USA with expiration dates in September and October 2020.

Risk

Confusing the anesthetic type or concentration due to mislabeled packaging can lead to the administration of the wrong medication or dosage. This poses a risk of ineffective anesthesia or adverse reactions if a practitioner relies on the conflicting information printed on the outer carton.

What You Should Do

Check your dental supply inventory for Articaine DENTAL (articaine hydrochloride 4% and epinephrine 1:100,000) in 50-cartridge cartons (1.7 mL each) with NDC 66312-601-16 and Reorder # 51116.
Verify the lot numbers and expiration dates on the packaging: look for Lot D02599A (exp. Sept 2020) and Lot D02608B (exp. October 2020).
Inspect the outer carton for conflicting text that mentions both '2% Xylocaine DENTAL' and 'Articadent DENTAL.'
Contact your healthcare provider or pharmacist for guidance regarding any concerns about medication recently administered from these lots.
Return any unused or incorrectly labeled cartons to the place of purchase for a refund and contact the manufacturer, Septodont Inc., for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

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

Affected Products

Product: Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000 (50 cartridges, 1.7 mL each)

Model:

NDC 66312-601-16

Reorder #: 51116

Recall #: D-1307-2019

Lot Numbers:

D02599A (exp. Sept 2020)

D02608B (exp. October 2020)

Date Ranges: September 2020, October 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82760

Status: Resolved

Manufacturer: Septodont Inc.

Sold By: DENTSPLY Pharmaceutical

Manufactured In: Canada, United States

Units Affected: 240 cartons of 50 glass cartridges each

Distributed To: Nationwide

Agency Last Updated: May 28, 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 dental supply inventory for Articaine DENTAL (articaine hydrochloride 4% and epinephrine 1:100,000) in 50-cartridge cartons (1.7 mL each) with NDC 66312-601-16 and Reorder # 51116.

Verify the lot numbers and expiration dates on the packaging: look for Lot D02599A (exp. Sept 2020) and Lot D02608B (exp. October 2020).

Inspect the outer carton for conflicting text that mentions both '2% Xylocaine DENTAL' and 'Articadent DENTAL.'

Contact your healthcare provider or pharmacist for guidance regarding any concerns about medication recently administered from these lots.

Return any unused or incorrectly labeled cartons to the place of purchase for a refund and contact the manufacturer, Septodont Inc., for further instructions.

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