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CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.
Many immune globulin products are licensed for storage at 36 to 46 degrees Fahrenheit, and some products may be stored at room temperature for all or part of the time before expiration. Because storage temperatures and times are specific to each product, you should follow the package insert recommendations for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products. Products requiring lower temperatures can be stored on wet ice. All of these products should not be frozen. If you have any questions about the storage of these products, you should consult the package inserts.
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