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© 2025 Patient Safety Authority
SAFETY ALERT
December 7, 2020
PRODUCT RECALL
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On October 27, Sunstar Americas Inc. issued a voluntary nationwide recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%. There is potential contamination of the product with Burkholderia lata. The Patient Safety Authority (PSA) received a report of a patient developing an infection that could be related to use of this product. The PSA advises that facilities review their stock and remove this product from distribution channels.
More information about the recall (including photos of the affected products) can be found at
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse#recall-announcement.
