Nationwide Recall Initiated for Contaminated CVS Health 12 Hour Sinus Relief Nasal Mist

Consumers are advised to stop using the recalled Nasal Mist immediately to prevent infection

Nationwide Recall Initiated for Contaminated CVS Health 12 Hour Sinus Relief Nasal Mist
Image: FDA
August 9, 2018

A microbiological contamination risk has prompted Product Quest Manufacturing to initiate a nationwide recall for CVS Health 12 Hour Sinus Relief Nasal Mist.

The impacted product was found to be contaminated with Pseudomonas aeruginosa.

What's the risk?

Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection, which can be life threatening in certain patient populations, such as those with cystic fibrosis or otherwise compromised immune systems.

Recalled Product Details

The affected CVS Health 12 Hour Sinus Relief Nasal Mist is used as a nasal decongestant and is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton.

The product comes in a white nasal spray bottle with an orange label containing a lot number of 173089J, a UPC code of 50428432365, and an expiration date of 09/19.

What should consumers do?

Consumers are advised to stop using the recalled CVS Health 12 Hour Sinus Relief Nasal Mist immediately and either discard it or return it to the place or purchase for a refund or replacement.

Consumers with questions or concerns about this recall can contact Product Quest Manufacturing at (386) 239-8787.

Anyone experiencing problems that may be related to taking or using this drug product should contact their physician or healthcare provider.