All Nasal Products, Baby Oral Gels Manufactured at a Florida Facility Are Recalled
The voluntary recall of 1 lot of CVS Health 12 Hour Sinus Relief Nasal Mist was expanded to include all nasal products and baby oral gels manufactured at the same Florida facility.
One lot of CVS Health 12 Hour Sinus Relief Nasal Mist has been voluntarily recalled by Product Quest Manufacturing.
The recall was issued due to microbial contamination, identified as
found in Lot# 173089J.
1Pseudomonas aeruginosa,
According to the FDA, Product Quest has opted to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility, out of an abundance of caution. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall.
1
The FDA has directed the recall to be carried out to the retail level. Product Quest has not received any reports of adverse events related to products included in the recall.
1
In a prepared statement, officials with the FDA said repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to infection, which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals.
In addition, repetitive use of an oral gel product containing a pathogen can potentially lead to infection which can be life threatening in certain patient populations, including babies or very young children.
11
The nasal and baby oral gel products included in the recall expansion are listed on the FDA’s website. The list of products include identification by item code, product description, lot #, and expiration date.
1
The FDA recently issued
related to microbial contamination that was later expanded.
In that warning, the FDA urged consumers not to use drug products, including homeopathic items, made by the North Carolina—based King Bio Inc. According to the FDA, those products, including items labeled as Dr. King’s, may pose a safety risk to people and pets due to high levels of microbial contamination at the manufacturing site.
Reference
- Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination [news release]. Silver Spring, MD; August 28, 2018: FDA website.http://www.pharmacytimes.com/link/214. Accessed August, 29, 2018.
- Dozens of Drug Products Recalled Due to Microbial Contamination.Pharmacy Timeswebsite.https://www.pharmacytimes.com/resource-centers/veterinary-pharmacy/dozens-of-drug-products-recalled-due-to-microbial-contamination. Published August 29, 2018. Accessed August 29, 2018.
