2 MediNatura nasal sprays sold in US recalled over potential life-threatening infections
by Raul Dancel · The Straits TimesTwo nasal sprays distributed across the US are being recalled for potentially causing life-threatening infections.
The US Food and Drug Administration (FDA) said on Dec 16 that MediNatura New Mexico is voluntarily recalling all lots of its ReBoost and ClearLife nasal sprays.
Tests have detected yeast, mould and other microbial contamination, including the antibiotic-resistant bacterium Achromobacter, in these products.
Achromobacter xylosoxidans can cause respiratory tract, bloodstream, urinary tract and wound infections, particularly in people with weakened immune systems or chronic lung disease such as cystic fibrosis.
“There is a reasonable probability that adverse health consequences, including life-threatening infections, will occur with use of the products in the immunocompromised population,” the FDA warned.
The Hawaii State Department of Health also announced the recall. It said symptoms may include fever, swollen sinuses, headaches, face pain or pressure and facial numbness.
ReBoost Nasal Spray is used to temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose and nasal itching.
The recall covers all ReBoost products packaged in a 20ml spray bottle with expiration dates of between December 2022 and December 2025. The NDC (National Drug Code) number is 62795-4005-9 and the UPC# (bar code) is 787647 10186 3.
ClearLife Allergy Nasal Spray is used to temporarily relieve minor allergy symptoms such as sinus pressure, runny or itchy nose, nasal congestion, allergic rhinitis, sneezing, itchy or watery eyes, allergy-related headache, and itchy throat and skin.
The recalled products are likewise packaged in a 20ml bottle, with expiration dates of between December 2022 and December 2025. The NDC number is 62795-4006-9 and the UPC# is 787647 10188 7.
“All customers should immediately discontinue using the products under recall,” the FDA said.
It said it has yet to receive any reports of “adverse events” related to the recalls.