Sunstar Americas, Inc. Issues Voluntary Nationwide Recall of GUM® Hydral Dry Mouth Relief Oral Spray Due to Possible Microbial Contamination
- S&P 500, Dow climb for third day and close at records
- Tesla (TSLA) China Numbers 'Robust' - Wedbush
- Apple (AAPL) Shares Seen as 'Attractive' as Recent Checks Show Continuously Strong Demand - Citi
- Amazon.com warehouse workers vote to reject forming union in Alabama
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
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 firstname.lastname@example.org 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:
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.
For more information:
Company Contact:Greg Belair847-794-4241Greg.email@example.com
Contact us:Phone: 1-800-528-8537 Email: firstname.lastname@example.org
Visit us at: https://www.gumbrand.com/news-announcements
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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Explore World Up Closer - DDPAI MINI5 4K Sharing Dash Cam
- C4 Therapeutics Presents Preclinical Data on CFT7455, a Novel IKZF1/3 Degrader for the Treatment of Hematologic Malignancies, at the AACR Annual Meeting 2021
- Fusion Pharmaceuticals Announces Preclinical Combination Data Demonstrating Enhanced Efficacy in Multiple Preclinical Tumor Models