Five lots of anti-gingivitis oral rinse GUM Paroex recalled due to microbial contamination

Starting date:
October 29, 2020
Posting date:
October 29, 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:

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

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 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 for the treatment of moderate to severe gingivitis, and for the management of 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.
Affected products
Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Expiry
Sunstar Americas Inc. GUM
Paroex
02384272 0.12% chlorhexidine gluconate C177GS July 31, 2022
C177GT July 31, 2022
C177GU July 31, 2022
C219DH August 31, 2022
C219DJ August 31, 2022

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

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