HOLLY HILL, Fla. — Product Quest Manufacturing is voluntarily recalling one lot of its CVS Health 12-Hour Sinus Relief Nasal Mist after the product was found to have had a microbiological contamination.
The affected Lot is No. 173089J. The product is a clear, colorless liquid.
According to the U.S. Food & Drug Administration, repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to an infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or those who are 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 FDA says.
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. A total of 16,896 units were released, with UPC code 50428432365. The product has a white bottle and an orange label with Sinus Relief stated in white lettering and CVS Health on the top left of the label.
Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which 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 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
