Sunstar Americas, Inc. Issues Voluntary Nationwide Recall of GUM® Hydral Dry Mouth Relief Oral Spray Due to Possible Microbial Contamination

Source: Yahoo! Finance
Date: February 18th, 2021

CHICAGO, Feb. 18, 2021 /PRNewswire/ — Sunstar Americas, Inc. (SAI) is voluntarily recalling GUM® Hydral Dry Mouth Relief Oral Spray products bearing an expiration date from 2021-11 through 2022-05 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia cepacia.

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, no adverse events have been reported to SAI related to this recall.

The oral spray, available through retail, is indicated for use for lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth:

• 1800R/1800RA GUM® Hydral Dry Mouth Relief Oral Spray is distributed in 2.0 fluid ounce Polyethylene Terephthalate (PET) bottles with white polypropylene caps and a separate spray nozzle.

GUM® Hydral Dry Mouth Relief Oral Spray was distributed Nationwide to Grocery and Drug Wholesalers, Grocery and Drug chains, Web distribution and sales, and direct to consumers.

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 [email protected] 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:

AFFECTED LOTS

SKU#	Lot	Exp
1800R	493538	2021/11
1800R	493539	2021/11
1800R	493540	2021/11
1800R	493541	2021/12
1800R	498339	2021/12
1800R	498340	2021/12
1800R	498341	2021/12
1800R	498342	2021/12
1800R	511571	2022/01
1800R	516383	2022/02
1800R	516384	2022/02
1800RA	C140DD	2022-05

 

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.

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.