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Avoid: Repeated freeze-thaw cycles, excessive heat exposure, prolonged exposure to air, direct light exposure, contamination of the vial stopper

Vasconcelos et al., 2025)

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DESCRIPTION SECTION DESCRIPTION SECTION Each mL of sterile aqueous solution contains: Active Ingredient: Cyanocobalamin (B 12 )..........1000 mcg Inactive Ingredients: sodium chloride 0.22% w/v, ammonium sulfate 0.1% w/v, citric acid 0.01% w/v, sodium citrate 0.008% w/v, and benzyl alcohol 1.0% v/v (preservative)

CDER Warning Letters Jump 50% in FY 2025 What That Means for Industry FDA enforcement is accelerating