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August 8, 2018: Nasal Spray Recall – CVS Health 12 Hour Sinus Relief Nasal Mist is Recalled Due To Bacterial Contamination

Nasal Spray Recall Announced – Product Quest Manufacturing of Holly Hill, Fl, has recalled Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, because the product was found to be contaminated with the potentially pathogenic bacterium, Pseudomonas aeruginosa.

The product recall announcement for CVS Health 12 Hour Sinus Relief Nasal Mist contained the following 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.”

Nasal Spray Recall Product Information

CVS Nasal Spray Recall – Product Images.

CVS Health 12 Hour Sinus Relief Nasal Mist is used as a nasal decongestant. The recalled product is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton (IFC), bearing Lot # 173089J and EXP 09/19. According to the manufacturer, 16,896 units were released with UPC code 50428432365. 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.

Nasal Spray Recall Advice – The manufacturer’s press release also indicated that consumers /distributors/retailers who have the recalled nasal spray are cautioned to “stop using the product and return it to the place of purchase or discard the product.” Consumers were also advised to “contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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