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

OTTAWA, ON, Dec. 24, 2020 /CNW/ -

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.

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:

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.

Advisory from October 29, 2020
OTTAWA - 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
The product is distributed through dental clinics to patients and through prescriptions filled by pharmacies in Canada. It contains 0.12% chlorhexidine gluconate.

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

Également disponible en français

SOURCE Health Canada

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