Biomic Sciences Recalls Contaminated Sprays

Biomic Sciences is recalling all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products after FDA-conducted testing raised microbial contamination concerns. The contaminants have been identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., and Paenibacillus sp. The products are used as a nasal rinse and are packaged in individual boxes of one or two nasal spray dispensers.

“In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection,” a recall notice says. (XXINSERT LINKXX)  

To date, Biomic Sciences says it has not received any adverse event reports related to the matter.