USA -Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

FDA

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. THolly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

Risk Statement: 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 # 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. Product was distributed Nationwide to retail outlets.

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