Medicine recalls
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| The United States: Sunstar Americas Inc. expands voluntary nationwide recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on 27 Oct 2020. The affected products are:
- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% 16 fl.oz. Product Code:1789P (all lots with expiration date from 31 Dec 2020 through 30 Sep 2022).
- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% 4 fl.oz. Product Code:1788P (all lots with expiration date from 31 Dec 2020 through 30 Sep 2022).
Use of the defective product in the immunocompetent host may result in 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.
To date, 29 adverse events have been reported to SAI related to this recall. 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.
The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA and Health Canada, and was posted on the Drug Office website since 29 Oct 2020, with the latest update posted on 28 Dec 2020.
Ends/Tuesday, Dec 29, 2020
Issued at HKT 15:00
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