GUM Paroex (anti-gingivitis oral rinse) being recalled due to microbial contamination that could lead to respiratory and other infections in patients

Starting date:

December 24, 2020

Posting date:

December 24, 2020

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

General Public, Healthcare Professionals

Identification number:

RA-74233

Last updated:
2020-12-24

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Summary

• Products: GUM Paroex (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) (DIN 02384272)
• Issue: Five lots contain Burkholderia lata, a bacteria that can cause serious respiratory and other infections.
• What to do: Do not use oral rinses labelled with one of the lot numbers listed in the table of affected products below.

• Issue
• What consumers should do
• Media Enquiries
• Public Enquiries

UPDATE: December 24, 2020 – Additional lots of GUM Paroex (anti-gingivitis oral rinse) being recalled because this product may be contaminated with the bacteria Burkholderia lata.

OTTAWA – Sunstar Americas Inc. is expanding its recall for its prescription anti-gingivitis oral rinse, GUM Paroex, to all lots on the Canadian market. The additional lots are being recalled, as a precaution, because they may be contaminated with the bacteria Burkholderia lata.

Health Canada is advising:

• Do not use rinses labelled with one of the lot numbers listed below.
• Consult your healthcare provider immediately if you’ve taken this product and are experiencing respiratory or other medical issues.
• Report any health product-related adverse reactions or complaints to Health Canada.

In addition to the lots that were recalled in October 2020, the affected new lots of GUM Paroex (DIN: 02384272 - 0.12% chlorhexidine gluconate) being recalled are:

Health Canada will monitor the effectiveness of the recall and continue to inform Canadians if new safety information arises.

Issue

Sunstar Americas, Inc. is recalling five lots of its prescription anti-gingivitis oral rinse, GUM Paroex, after testing by the company revealed the presence of Burkholderia lata.

Burkholderia lata is a multi-drug-resistant bacteria that has a high potential to cause serious respiratory and other infections in patients with underlying illnesses, such as cystic fibrosis and chronic granulomatous disease, or who are immunocompromised (such as some elderly individuals, people who are HIV positive and cancer patients undergoing chemotherapy or hemodialysis).

Hospitalized patients who have catheters, are mechanically ventilated or are in the intensive care unit are at risk of severe, life-threatening infections if exposed to this bacteria through the contaminated product.

Those with a healthy immune system who use the contaminated product may risk infections requiring treatment with antibiotics.

GUM Paroex is a licensed, prescription anti-gingivitis oral rinse used to treat moderate to severe gingivitis, and for to manage associated gingival bleeding and inflammation between dental visits. The product is distributed to patients in Canada through dental clinics and pharmacies.

Health Canada is monitoring the effectiveness of the company’s recall and the implementation of any necessary corrective and preventative actions.

What consumers should do

• Do not use rinses labelled with one of the lot numbers listed in the table of affected products below.
• Consult your healthcare provider immediately if you’ve taken this product and are experiencing respiratory or other medical issues.
• Report any health product-related adverse reactions or complaints to Health Canada.

Media Enquiries

Health Canada

(613) 957-2983
hc.media.sc@canada.ca

Public Enquiries

(613) 957-2991

1-866 225-0709
hcinfo.infosc@canada.ca

Images

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