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Due to potential bacterial contamination, the company is voluntarily recalling a larger batch of its prescription oral rinse.
Sunstar Americas recently announced that it has expanded its voluntary recall to cover a larger batch of its Paroex® Chlorhexidine Gluconate Oral Rinse USP, 12% due to potential contamination with the bacteria Burkholderia lata.
The original recall was issued in October 2020, and it has now been expanded to include products bearing an expiration date from 12/2020 – 09/2022. The infected products could potentially lead to oral, or systemic infections that could become life-threatening.
To date, 29 adverse events related to this recall have been reported to Sunstar. Affected patients tested positive for Burkholderia lata infections. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with coronavirus disease 2019, is particularly unsafe.
The specific product lines covered under this recall are:
Sunstar is notifying its distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should immediately stop using or dispensing them.
Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email email@example.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Affected products and lot numbers follow below:
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.