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Several events can invalidate the BUD even before the calendar date arrives: Sustained exposure above 25 C (a day or more at room temperature, a hot car) Any exposure below 0 C (accidental freezing) Prolonged exposure to direct sunlight or bright indoor light Mechanical stress: vigorous shaking, dropping the vial repeatedly, transport without padding Visible cloudiness, color change, or particulates regardless of calendar date Septum compromise (cracked or visibly damaged rubber stopper) Loss of refrigeration during power outage exceeding the cooler maintenance window Patients who experience any of these events should document the situation and contact the dispensing pharmacy
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