The FDA announced a voluntary recall of a sinus nasal spray from CVS due to possible microbiological contamination.
The product recalled is CVS Health 12 Hour Sinus Relief Nasal Mist.
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The FDA said the following in a press 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.
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 with UPC code 50428432365.
The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is lot number 173089J, EXP 09/19. The product can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health on top left. The IFC containing the bottle is also orange and contains the same wording. Lot 173089J and EXP 09/19 is coded on the side panel of the carton. The product was distributed Nationwide to retail outlets.
Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers, distributors and retailers that have a product that is being recalled should stop using the product and return it to the place of purchase or discard the product.
Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 a.m. to 4 p.m., EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.