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Second mouthwash in two weeks recalled for a possible bacterial contamination

A second prescription mouthwash made by Sunstar Americas has been recalled for a possible bacterial contamination 13 days after another oral rinse from Sunstar was recalled for the same reason.

Lohxa pulled five lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free on Tuesday after, the company’s FDA-posted recall announcement said, Sunstar told Lohxa the mouthwash could have the bacteria Burkholderia lata. Lohxa gets Chlorhexidine Gluconate from Sunstar and repackages it for sale to hospital pharmacies.

The Burkholderia lata problem caused Sunstar to recall 37 lots of GUM Paroex oral rinse on Oct. 27. That contamination can cause, the notice states, “oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.”

Lots covered in the Lohxa recall are T0901A, expiration 1/2021; T08292A and T10011A, expiration 2/2021; M10193A and T10223A, expiration 3/2021.

Label of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free
Label of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free FDA

Those with questions about this recall can email info@lohxa.com or call 800-641-5564, Monday through Friday, 8 a.m. to 5 p.m., Eastern time.

If you suffer a medical problem from this or any other drug, you should first contact a medical professional. Then, report the problem to the FDA’s MedWatch Adverse Event Reporting program either via the FDA website or by a form obtained at 800-332-1088.

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This story was originally published November 10, 2020 at 5:17 AM with the headline "Second mouthwash in two weeks recalled for a possible bacterial contamination."

David J. Neal
Miami Herald
Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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