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In one of two warning letters sent to Empower in April, the FDA cited failures to monitor areas where sterile drugs are prepared and a failure to appropriately sterilize equipment

Metabolic pathways: B12 is a cofactor in two critical reactions: Methylmalonyl-CoA mutase: Converts methylmalonyl CoA (from odd-chain fatty acids and some amino acids) into succinyl-CoA, which enters the Krebs (TCA) cycle to make ATP (cellular energy)

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This helps ensure a smooth and even dissolution process