Product Quest Manufacturing, after recalling CVS Health 12 Hour Sinus Relief Nasal Mist for microbial contamination, is now recalling all lots of nasal products and baby oral gels that were made at that company’s Florida facility. While there is no known microbial contamination associated with those products, they are issuing the recall out of an abundance of caution.
The microbes found in the nasal mist product were identified as Pseudomonas aeruginosa. Repetitive use of a nasal spray or other nasal product that contains this pathogen can lead to an infection that can be life-threatening in certain populations. People with compromised immune system or with cystic fibrosis are most susceptible to serious complications with this type of infection.
Repetitive use of an oral gel product can also lead to colonization and serious infections. The groups most susceptible to these types of complications are babies and very young children. No reports of any adverse events have been received by the company to date in connection with this recall.
The recall notice states that the products included in this recall are listed in Attachment A, but that link is broken at the FDA site. Product Quest is notifying customers by oral and written communication and is arranging for the return and replacement of all of the recalled products.
If you have purchased any nasal sprays or baby oral gels within expiration dates from this company, do not use them. Throw them away or take them back to the store where you purchased them for a refund.
You can report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting Program. Fill out the online form, or request a form and mail it to the FDA.
