HOLLY HILL, Fla. (FOX 35 WOFL) - Nasal-sprays and baby oral gels from a Holly Hill facility are being recalled after finding a microbial contamination.
A recall of Product Quest Manufacturing's CVS Health 12 Hour Sinus Relief Nasal Mist has been expanded to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company's Florida facility, reports the U.S. Food and Drug Administration (FDA).
Based out of Holly Hill, Florida, Product Quest originally recalled the CVS-brand nasal spray due to finding a microbial contamination identified as Pseudomonas aeruginosa. However, out of an abundance of caution, they have decided to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility.
In a release, the FDA said 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.
The FDA has also acknowledged that there is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. And they say that to the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date.
For a full list of the products included in this expanded recall, visit HERE.
Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at 704-939-4342. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
For more information on this recall, visit HERE.