More mouthwash recalled for a possible bacterial contamination with COVID concerns
Last week’s expanded recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse after bacterial contamination sickened some users has expanded again to include a year’s worth of single dose cups of the prescription mouthwash.
Sunstar Americas makes the oral rinse and issued last week’s recall after learning 29 people had been infected with Burkholderia lata bacteria. This recall is from Precision Dose, which repackages the gingivitis medicine in 15 ml cups for medical professional use.
This recall notice repeated the language of last week’s, which stated that using the contaminated mouthwash can lead to “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.”
In making last week’s expanded recall, Sunstar Americas also said, “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with COVID-19, is particularly unsafe.”
But no illnesses have been credited to the Precision Dose distributed mouthwash.
The recalled 30-pack cases of the cups have NDC No. 68094-028-62 and lot Nos. 502037; 502040; and 502043 with expiration date 01/31/2021; 502494 with expiration date 08/31/2021; 502759 with expiration date 10/31/2021; and 502771 with expiration date 11/30/2021.
The recalled 100-pack cases of the cups have NDC No. 68094-028-61 and lot Nos. 502037; 502040; and 502043 with expiration date 01/31/2021; 502494 and 502757 with expiration date 08/31/2021; 502677 with expiration date Sept. 30, 2021; 502693 and 502728 with expiration date 10/31/2021; 502771 and 502784 with expiration date 11/30/2021; 502824 with expiration date 12/31/2021; and 502925 with expiration date 02/28/2022.
If you have questions about this recall, contact Precision Dose at 800-397-9228, Monday through Friday, 9 a.m. to 5:30 p.m., Eastern time, or by emailing customercare@precisiondose.com.
Report any medical issues from using this mouthwash to a medical professional. Then, contact the FDA’s MedWatch Adverse Event Reporting program either via the FDA website or by faxing a form obtained at 800-332-1088.
This story was originally published January 4, 2021 at 10:28 AM with the headline "More mouthwash recalled for a possible bacterial contamination with COVID concerns."
