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:
- Source of recall:
- Health Canada
- Important Safety Information, Contamination
- General Public, Healthcare Professionals
- Identification number:
- 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.
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.
|Company||Product Name/Active Pharmaceutical Ingredient (API)||DIN||Strength||Lot||Expiry|
|Sunstar Americas Inc.||
|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|
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