OTC Nasal Decongestant Recalled for Contamination


August 19, 2018

August 8, 2018 (empr.com) An over-the-counter nasal decongestant has been recalled due to microbial contamination, according to an online news story from empr.com.

The recall affects one lot of CVS Health 12-Hour Sinus Relief Nasal Mist (oxymetazoline HCI 0.05%). The product was found to be contaminated with pseudomonas aeruginosa. Pseudomonas aeruginosa is a gram-negative bacteria that can cause serious infections in people, especially children and people who are immunocompromised. 

The nasal decongestant is sold at CVS Pharmacy stores under the CVS Health brand and bears the lot number 173089J. It has an expiration date of 09/19 and is packaged in 0.5 fluid ounce bottles. Use of the contaminated spray can lead to colonization and infection, which can be potentially life-threatening. At this time, however, no reports of illness due to contaminated nasal decongestant have been received. 

Consumers with questions about their products can contact Product Quest (the manufacturing company) by calling (386) 239-8787. Health care providers are encouraged to contact the U.S. Food and Drug Administration if they treat anyone with suspected contamination or to submit a report to the FDA’s MedWatch Adverse Event Reporting system. 

Consumers can also contact the FDA and submit reports though the Adverse Event Reporting system. The FDA monitors this system and takes action when a large number of reports come in regarding a certain product or complication. Adverse reporting can result in product recall, label changes, and additional clinical trials. Consumers are also free to contact the manufacturer and retailer to alert them to potential problems with products they buy. 

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