Nasal spray recalled nationwide over microbiological contamination
A sinus relief nasal spray was recalled Wednesday after a microbiological contaminant was found in the fluid, according to the Food and Drug Administration.
Product Quest Manufacturing recalled one specific lot of CVS Health 12 Hour Sinus Relief Nasal Mist.
Officials say the clear, colorless liquid was contaminated with Pseudomonas aeruginosa.
According to the FDA, repeated use of the contaminated product could lead to colonization and infection. This could be life threatening for people who are immuno-compromised, have cystic fibrosis or face other similar conditions.
The FDA reports that no one has experienced and reported adverse effects connected to this recall to the best of Product Quest’s knowledge.
The recall is for 16,896 units which were distributed across the country to retail outlets.
To find out if a unit of the CVS Health nasal mist has been recalled, check the side of the carton. Recalled units are labeled “Lot 173089J” and “EXP 09/19.”
This nasal mist is a nasal decongestant packaged in a white, 0.5 fluid ounce bottle with an orange label.
The company plans to return or replace recalled products.
The FDA advises anyone with the recalled product to either return it to where it was purchased or throw it away.
Anyone experiencing problems possibly related to the recalled product are directed to contact their physician or healthcare provider. Adverse reactions and quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail or by fax.
To mail or fax a report, download the FDA form available online or call 1-800-332-1088 to request a form. Once completed, the form can be mailed to the address on the pre-addressed form or faced to 1-800-FDA-0178.
Any questions are referred to Product Quest Manufacturing LLC, which can be called at (386) 239-8787, Monday through Friday from 8 a.m. to 4 p.m., EST.