Humic Acid Nasal Sprays Recalled During Potential For Sales Boost Due To Phenylephrine Doubts
Biomic Sciences recalls all lots of ION* Sinus Support and ION* Biome Sinus after FDE testing found microbial contamination causing reasonable probability of life-threatening adverse events for patients or people who recently underwent nasal or sinus surgery.
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“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.
Two days after FDA advisory panel’s meeting to discuss whether oral phenylephrine is effective for nasal congestion, complaints filed in federal court in multiple states alleging manufacturers knowingly misled public about ingredient’s efficacy. FDA’s potential response to NDAC’S finding wouldn’t come as soon.
Action on unanimous statement by Nonprescription Drug Advisory Committee could be one of FDA’s first in its more streamlined process for making OTC monograph changes. Regulatory change on phenylephrine available in US also could reach OTC and Rx drugs available through applications.