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 [...]