CVS Nasal Spray Recall Issued Amid Concerns About Pseudomonas Aeruginosa Contamination

Certain CVS-brand nasal decongestant sprays sold at stores nationwide may be contaminated with Pseudomonas aeruginosa bacteria, which could pose serious and potentially life-threatening health risks.

A CVS Sinus Relief Nasal Mist recall was announced by the U.S. Food and Drug Administration (FDA) on August 8, after routine testing confirmed the presence of Pseudomonas aeruginosa. While, no injuries or infections have been reported to date, this could pose a serious risk for individuals with cystic fibrosis or a compromised immune system.

Pseudomonas aeruginosa is a common bacterium that can cause disease in plants, animals and humans and can be found in many different environments including soils, water and plant or animal tissue. The infection may cause mild to severe health consequences in humans including fever, chills, body aches, light-headedness, rapid pulse, heavy breathing, nausea and vomiting, diarrhea and decreased urination.

For most individuals the infection can be treated with common antibiotics, however for those with weakened immune system, especially patients diagnosed with cystic fibrosis, the infection can cause lung infections due to its ability to thrive in moist environments.

The FDA is warning users that repetitive use of a nasal spray containing a gram-negative pathogen, such as Pseudomonas aeruginosa, could potentially lead to colonization and subsequent infections that can be life threatening in certain patient populations.

The recall includes CVS Health 12 Hour Sinus Relief Nasal Mist products that were sold in 0.5 ounce bottles. The recalled products are marked with UPC code 50428432365 and Lot# 173089J with expiration of September 2019. The products can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health marked on the top left of the container.

The recalled CVS nasal sprays were manufactured by Product Quest Manufacturing LLC. According to the recall, an estimated 16,896 units were distributed across the United States to CVS Health Stores and various other retailers.

Product Quest is sending written correspondence to any and all known retailers and customers warning them of the potential contamination with instruction to stop using the products immediately. Customers with additional questions or concerns regarding the recall or products should contact Product Quest at 386-239-8787.