Medical Food Firm Stands Its Ground After FDA Repeats Recall Request
This article was originally published in The Rose Sheet
Primus Pharmaceuticals say an insert in packages of its Limbrel capsules prescribed to manage metabolic processes associated with osteoarthritis advises that the ingredient baicalin could cause the lung condition acute hypersensitive pneumonitis and elevated liver enzymes in users with allergies to the flavonoid.
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Primus Pharmaceuticals voluntarily recalls unexpired lots of its Limbrel medical food available in 250 and 500 mg capsules. Other recent nutritional product sector recalls include Bulletproof 360's protein dietary supplement after a labeling error omitted milk as an ingredient.
FDA receives 194 adverse event reports regarding Primus Pharmaceuticals''s Limbrel medical food capsules, including two about "potentially life-threatening medical conditions." The agency says a likely relation was found between the product and the conditions reported in 30 of the AERs.
Marketing consultant Buzzback surveyed 800 consumers in March, prior to novel coronavirus shutdowns in the two countries, to identify ingredients that offer opportunities for brands in health care, wellness and skin care.