Nearly 17000 CVS Health 12-Hour Sinus Relief Nasal Mist is being voluntarily recalled due potentially life-threatening effects for some users.
Product Quest Manufacturing is recalling Lot #173089J with UPC Code 50428432365, which expires 09/19. The lot number and expiration can be found on the side panel of the carton. This 0.5 fluid ounce bottle nasal decongestant comes in a folding carton (box). The product is a clear and colorless mist used to relieve nasal congestion. The product was distributed Nationwide to retail outlets.
The product was recalled due to the presence of a microbiological contamination identified as Pseudomonas aeruginosa. “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 immunocompromised,” Product Quest Manufacturing representatives said. “To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall.”
Consumers are being notified through oral and written communication. The company is arranging return/replacement of the recalled products. Those who have the product should stop using it and return it to the place of purchase.
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration
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