Medications & Supplements/Prescription Drugs

Sunstar Americas, Inc.: Paroex (Chlorhexidine Gluconate) Oral Rinse Recalled for Potential Contamination

Agency Publication Date: January 11, 2021

Summary

Sunstar Americas, Inc. is recalling approximately 1,277,466 bottles of Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, because an FDA inspection found potential bacterial contamination with Burkholderia cepacia complex (BCC). The recall affects over 1 million 1-pint bottles and more than 255,000 4-ounce bottles distributed nationwide. The facility was also found to have inadequate cleaning procedures and microbiological testing, creating insanitary manufacturing conditions.

Risk

The oral rinse may be contaminated with BCC bacteria, which can cause serious, life-threatening infections in people with compromised immune systems or underlying lung conditions like cystic fibrosis. Use of the contaminated product in the mouth could lead to respiratory or systemic infections.

What You Should Do

Check your prescription oral rinse bottles to see if they are Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free.
Identify affected products by checking for NDC numbers 52376-021-02 (1 pint / 473mL) or 052376-021-04 (4 fl oz / 118 mL) and expiration dates between December 31, 2020, and September 30, 2022.
Stop using the recalled oral rinse immediately to avoid potential bacterial exposure.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse health effects.
Return any unused product to the pharmacy where you purchased it for a refund.
Contact Sunstar Americas, Inc. at their Schaumburg, IL facility for further instructions regarding this recall.
For additional questions or to report a complaint, call 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

Pharmaceutical refund

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

Affected Products

Product: Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free (1 pint / 473mL)

Model:

NDC 52376-021-02

Lot Numbers:

ALL LOTS

Date Ranges: Dec. 31, 2020 through Sep. 30, 2022 (Expiration)

Product: Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free (4 fl oz / 118 mL)

Model:

NDC 052376-021-04

Lot Numbers:

ALL LOTS

Date Ranges: Dec. 31, 2020 through Sep. 30, 2022 (Expiration)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87052

Status: Active

Manufacturer: Sunstar Americas, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: a) 1,021,914 bottles; b) 255,552 bottles

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

Check your prescription oral rinse bottles to see if they are Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free.

Identify affected products by checking for NDC numbers 52376-021-02 (1 pint / 473mL) or 052376-021-04 (4 fl oz / 118 mL) and expiration dates between December 31, 2020, and September 30, 2022.

Stop using the recalled oral rinse immediately to avoid potential bacterial exposure.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse health effects.

Return any unused product to the pharmacy where you purchased it for a refund.

Contact Sunstar Americas, Inc. at their Schaumburg, IL facility for further instructions regarding this recall.

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

Affected Products

Product: Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free (1 pint / 473mL)

Model:

NDC 52376-021-02

Lot Numbers:

ALL LOTS

Date Ranges: Dec. 31, 2020 through Sep. 30, 2022 (Expiration)

Product: Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free (4 fl oz / 118 mL)

Model:

NDC 052376-021-04

Lot Numbers:

ALL LOTS

Date Ranges: Dec. 31, 2020 through Sep. 30, 2022 (Expiration)