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In the first, issued in March 2021, the FDA indicated that travel restrictions due to the COVID-19 pandemic prevented a timely inspection of the companys European contract manufacturing site

Overexposure to bismuth may cause extreme drowsiness (somnolence) and neurologic disturbances such as confusion, difficulty in concentration, hallucinations, delusions, myoclonic jerks, tremors, seizures, an impaired ability to coordinate voluntary movements (ataxia), and/or inability to stand or walk

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Burgess KM, Renaud JB, McDowell T, Sumarah MW (2016) Mechanistic insight into the biosynthesis and detoxification of fumonisin mycotoxins

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The second is recycling biopterin, which is needed to produce neurotransmitters