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:

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.

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:

Affected lots
Lot: Expiry Lot: Expiry Lot: Expiry Lot: Expiry
A333LF 2020/12 B066LG 2021/03 B227DX 2021/08 C030HK 2022/02
A333LG 2020/12 B070AP 2021/03 B227EK 2021/08 C142DF 2022/05
A333LH 2020/12 B070AQ 2021/03 B227EL 2021/08 C142DG 2022/05
A333LJ 2020/12 B070AR 2021/03 B234FD 2021/08 C142DH 2022/05
B003HM 2021/01 B136HM 2021/05 B234FE 2021/08 C142DJ 2022/05
B003HN 2021/01 B141HU 2021/05 B234FF 2021/08 C142DK 2022/05
B003HP 2021/01 B141HV 2021/05 B304LB 2021/11 B009JK 2021/01
B003HQ 2021/01 B141HW 2021/05 B304LC 2021/11 B009JL 2021/01
B003HR 2021/01 B178FL 2021/07 B311AM 2021/11 B031CD 2021/02
B003HS 2021/01 B178FM 2021/07 C009LV 2022/01 B227DW 2021/08
B003HT 2021/01 B178FN 2021/07 C009LW 2022/01 C016BJ 2022/01
B009JG 2021/01 B199KR 2021/07 C016BH 2022/01    
B009JH 2021/01 B199KS 2021/07 C030HH 2022/02    
B009JJ 2021/01 B199KT 2021/07 C030HJ 2022/02    

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.
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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