CVS Health 12 Hour Sinus Relief Nasal Mist .5 oz bottle has been recalled after the product was found to have had microbiological contamination identified as Pseudomonas aeruginosa, according to the Food and Drug Administration.
The product is used as a nasal decongestant and is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton.
16,896 units were released nationwide with UPC code 50428432365.
The affected CVS Health 12-Hour Sinus Relief Nasal Mist lot is Lot # 173089J, EXP 09/19. The lot number can be found on the side panel of the carton.
According to the recall release, "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 immuno-compromised. To the best of Product Quest's knowledge, the company has not received any reports of adverse events related to this recall."
Product Quest is notifying its customers via oral and written communication and is arranging for the return or replacement of all recalled products.
Anyone that has the affected spray is being asked to stop using the product and return it to the place of purchase or throw it away.
Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 am to 4 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
CVS recalls nasal mist due to microbiological contamination