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Sunstar Americas, Inc., is recalling certain Paroex Oral Rinse products which may be contaminated with the multi-drug resistant bacteria Burkholderia lata, which causes severe opportunistic infections.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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Update: Sunstar Expands Recall of Gluconate Oral Rinse USP 0.12

Sunstar Americas, Inc. is recalling Paroex Chlorhexidine Gluconate Oral Rinse USP [1], 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 over potential contamination with Burkholderia lata, according to an FDA Recall Notice issued on 12/28/20.

“To date, 29 adverse events have been linked to recalled oral rinse,” FDA said. “Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”

This is an expansion of the recall initially announced on Oct. 27, 2020.

Chlorhexidine Gluconate Oral Rinse

What’s the Problem with Paroex Chlorhexidine Gluconate Oral Rinse USP?

This recall affects Paroex Gluconate USP, 0.12% products with expiration dates between 6/30/22 and 9/30/22 to the consumer level, according to the U.S. Food & Drug Administration (FDA) [2].

“Use of the defective product with corresponding expiration dates in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy,” FDA said. “In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.”

The recalled paroex oral rinse is packaged as follows:

  • 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup
  • 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse.

The recalled product was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

If you were prescribed any Paroex that is affected by this recall, you should stop using it immediately. “SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products,” FDA said.

This recall began on October 28, 2020.

Related Article: Oral Rinse Recalled for Burkholderia Lata Contamination

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