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

February 18, 2021 8:43 PM EST

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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 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:

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.

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.

For more information:

Company Contact:Greg Belair847-794-4241Greg.belair@us.sunstar.com

Contact us:Phone: 1-800-528-8537 Email: us.pcr@us.sunstar.com

Visit us at: https://www.gumbrand.com/news-announcements

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/sunstar-americas-inc-issues-voluntary-nationwide-recall-of-gum-hydral-dry-mouth-relief-oral-spray-due-to-possible-microbial-contamination-301231407.html

SOURCE Sunstar Americas, Inc.



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