Wellness

[Mindy D]

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Summary

Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Drugs Reason for Announcement:

Potential contamination with Burkholderia lata

Company Name: Precision Dose Inc. Brand Name:

GUM Paroex

Product Description:

Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups

---

Company Announcement

Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata.

From information provided by the manufacturer, Sunstar Americas, Inc., 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 pneumonia and bacteremia. To date, no adverse events have been reported to Precision Dose, Inc. related to this recall.

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 and the product impacted is:

• Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62
• Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers.

Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228(Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com. Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product.

Affected products and lot numbers follow below:

AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

LOT NUMBER EXPIRATION DATE NDC NUMBER

502037	01/31/2021	68094-028-61 68094-028-62
502040	01/31/2021	68094-028-61 68094-028-62
502043	01/31/2021	68094-028-61 68094-028-62
502494	08/31/2021	68094-028-61 68094-028-62
502757	08/31/2021	68094-028-61
502677	09/30/2021	68094-028-61
502693	10/31/2021	68094-028-61
502728	10/31/2021	68094-028-61
502759	10/31/2021	68094-028-62
502771	11/30/2021	68094-028-61 68094-028-62
502784	11/30/2021	68094-028-61
502824	12/31/2021	68094-028-61
502925	02/28/2022	68094-028-61

Patients should contact their physician or healthcare provider if they have additional questions or concerns. 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
• Regular Mail or Fax: Download form 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Precision Dose, Inc.

Precision Dose, Inc. is an American company headquartered in the Midwest specializing in the commercial repackaging of unit dose products.

For more information:

Contact Us:

Phone: 1 (800) 397-9228
Email: customercare@precisiondose.com

Visit Us:
www.precisiondose.comExternal Link Disclaimer

Company Contact:
Mark Franzen
1 (800) 397-9228 x226
mfranzen@precisiondose.com

---

Company Contact Information

Consumers: Precision Dose, Inc. 1-800-397-9228 customercare@precisiondose.com

[Mindy D]

Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Summary

Company Announcement Date: December 28, 2020 FDA Publish Date: December 28, 2020 Product Type: Drugs Reason for Announcement:

Potential contamination with Burkholderia lata

Company Name: Sunstar Americas, Inc. Brand Name:

Paroex

Product Description:

Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz

---

Company Announcement

Schaumburg, Illinois, 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 October 27, 2020.

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 and 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, is safety sealed, and is decorated with a multiple-panel wrap-around label.
• 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images below

Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.

SAI is notifying its direct 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 stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.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:

Product name:

Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:

16 fl.oz. Amber Bottles

NDC #:

052376-021-02

Product Code:

1789P

Lots Recalled:

ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

 

Product name:

Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form:

4 fl.oz. Amber Bottles

NDC #:

052376-021-04

Product Code:

1788P

Lots Recalled:

ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

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
• Regular Mail or Fax: Download form 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

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

---

Company Contact Information

Consumers: Sunstar Americas 1-800-528-8537 us.pcr@us.sunstar.com