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Record the duration of increased temperature exposure. For example, the temperature of the freezer was 0 degrees Fahrenheit at noon on day 1 when the power failed; 15 degrees Fahrenheit at 6 PM on day 2 when the power was restored; 10 degrees Fahrenheit at 10 PM on day 2; and 0 degrees Fahrenheit at 7 AM on day 3. This information about time/temperature duration can enable calculations to be made by the product manufacturer, in consultation with FDA as necessary, about the continued potency of the involved products.
The information above concerning the storage and recording of time/temperature conditions are applicable to other non-blood biologicals requiring refrigeration or frozen storage.
Vials containing vaccine exposed to flood waters should be considered contaminated and also likely to have been exposed to temperatures outside of those recommended for cold chain storage, and should be discarded.
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