Medications & Supplements/Prescription Drugs

Sunstar Americas, Inc.: Paroex Oral Rinse Recalled Due to Microbial Contamination

Agency Publication Date: November 23, 2020

Summary

Sunstar Americas, Inc. is recalling approximately 129,958 bottles of Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, because the product may be contaminated with the bacteria Burkholderia lata. This prescription-only alcohol-free mouthwash was sold in 1-pint (473 mL) and 4-fluid ounce (118 mL) bottles nationwide. Use of the contaminated product can lead to serious, life-threatening infections, particularly in people with weakened immune systems or underlying respiratory conditions. Consumers should immediately stop using the oral rinse and contact their healthcare provider or pharmacist for guidance on returning the product and obtaining a refund.

Risk

The oral rinse may be contaminated with Burkholderia lata, a bacteria that can cause severe infections in the blood or lungs, especially in patients who are immunocompromised or have existing lung diseases. While healthy individuals may resist infection, those with risk factors could face life-threatening health complications from using the contaminated rinse.

What You Should Do

Identify if you have the affected 1-pint (473 mL) bottles (NDC 52376-021-02) by checking for the following lot numbers: C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR (Exp 6/30/2022); C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN (Exp 7/31/2022); C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS (Exp 8/31/2022); or C240GM, C240GP, C240GQ, C240GR (Exp 9/30/2022).
Identify if you have the affected 4-fluid ounce (118 mL) bottles (NDC 52376-021-04) by checking for lot number C191KR (Exp 7/31/2020).
Stop using the recalled oral rinse immediately to prevent the risk of infection.
Contact your healthcare provider or pharmacist for medical guidance and to discuss alternative treatments.
Return any unused bottles of the recalled product to your pharmacy to receive a refund.
Contact Sunstar Americas, Inc. at their facility in Schaumburg, Illinois, or visit their website for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: Return the product to the place of purchase for a refund and consult a healthcare professional regarding the potential for infection.

Affected Products

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

Model:

NDC 52376-021-02

Lot Numbers:

C170FY (Exp 6/30/2022)

C170FZ (Exp 6/30/2022)

C170GA (Exp 6/30/2022)

C170GB (Exp 6/30/2022)

C170GC (Exp 6/30/2022)

C177GP (Exp 6/30/2022)

C177GQ (Exp 6/30/2022)

C177GR (Exp 6/30/2022)

C191KS (Exp 7/31/2022)

C191KT (Exp 7/31/2022)

C191KU (Exp 7/31/2022)

C191KW (Exp 7/31/2022)

C191KX (Exp 7/31/2022)

C191KY (Exp 7/31/2022)

C198LJ (Exp 7/31/2022)

C198LK (Exp 7/31/2022)

C198LL (Exp 7/31/2022)

C198LM (Exp 7/31/2022)

C205BH (Exp 7/31/2022)

C205BJ (Exp 7/31/2022)

C205BK (Exp 7/31/2022)

C205BL (Exp 7/31/2022)

C205BM (Exp 7/31/2022)

C205BN (Exp 7/31/2022)

C219DK (Exp 8/31/2022)

C219DL (Exp 8/31/2022)

C219DM (Exp 8/31/2022)

C219DN (Exp 8/31/2022)

C219DP (Exp 8/31/2022)

C219DQ (Exp 8/31/2022)

C219DR (Exp 8/31/2022)

C219DS (Exp 8/31/2022)

C240GM (Exp 9/30/2022)

C240GP (Exp 9/30/2022)

C240GQ (Exp 9/30/2022)

C240GR (Exp 9/30/2022)

Date Ranges: Exp 6/30/2022, Exp 7/31/2022, Exp 8/31/2022, Exp 9/30/2022

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

Model:

NDC 52376-021-04

Lot Numbers:

C191KR (Exp 7/31/2020)

Date Ranges: Exp 7/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86656

Status: Resolved

Manufacturer: Sunstar Americas, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: a) 116,662 bottles; b) 13,296 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

Risk

What You Should Do

Identify if you have the affected 1-pint (473 mL) bottles (NDC 52376-021-02) by checking for the following lot numbers: C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR (Exp 6/30/2022); C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN (Exp 7/31/2022); C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS (Exp 8/31/2022); or C240GM, C240GP, C240GQ, C240GR (Exp 9/30/2022).

Identify if you have the affected 4-fluid ounce (118 mL) bottles (NDC 52376-021-04) by checking for lot number C191KR (Exp 7/31/2020).

Stop using the recalled oral rinse immediately to prevent the risk of infection.

Contact your healthcare provider or pharmacist for medical guidance and to discuss alternative treatments.

Return any unused bottles of the recalled product to your pharmacy to receive a refund.

Contact Sunstar Americas, Inc. at their facility in Schaumburg, Illinois, or visit their website for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

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

Model:

NDC 52376-021-02

Lot Numbers:

C170FY (Exp 6/30/2022)

C170FZ (Exp 6/30/2022)

C170GA (Exp 6/30/2022)

C170GB (Exp 6/30/2022)

C170GC (Exp 6/30/2022)

C177GP (Exp 6/30/2022)

C177GQ (Exp 6/30/2022)

C177GR (Exp 6/30/2022)

C191KS (Exp 7/31/2022)

C191KT (Exp 7/31/2022)

C191KU (Exp 7/31/2022)

C191KW (Exp 7/31/2022)

C191KX (Exp 7/31/2022)

C191KY (Exp 7/31/2022)

C198LJ (Exp 7/31/2022)

C198LK (Exp 7/31/2022)

C198LL (Exp 7/31/2022)

C198LM (Exp 7/31/2022)

C205BH (Exp 7/31/2022)

C205BJ (Exp 7/31/2022)

C205BK (Exp 7/31/2022)

C205BL (Exp 7/31/2022)

C205BM (Exp 7/31/2022)

C205BN (Exp 7/31/2022)

C219DK (Exp 8/31/2022)

C219DL (Exp 8/31/2022)

C219DM (Exp 8/31/2022)

C219DN (Exp 8/31/2022)

C219DP (Exp 8/31/2022)

C219DQ (Exp 8/31/2022)

C219DR (Exp 8/31/2022)

C219DS (Exp 8/31/2022)

C240GM (Exp 9/30/2022)

C240GP (Exp 9/30/2022)

C240GQ (Exp 9/30/2022)

C240GR (Exp 9/30/2022)

Date Ranges: Exp 6/30/2022, Exp 7/31/2022, Exp 8/31/2022, Exp 9/30/2022

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

Model:

NDC 52376-021-04

Lot Numbers:

C191KR (Exp 7/31/2020)

Date Ranges: Exp 7/31/2020