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Most refrigerated vaccines are relatively stable at room temperature for limited periods of time, although certain vaccines are temperature-sensitive. Products stored in a closed refrigerator (or freezer, if appropriate) during a power outage may maintain their potency unless the power outage is of such duration that the refrigerator’s (or freezer’s) internal temperature rises significantly. It is recommended that thermometers be located in the refrigerator and freezer section so that temperatures can be read when power resumes to see if excursions outside of recommended temperatures have occurred. The „How Supplied/Storage and Handling“ section of the product label may also be consulted for information. Most vaccine manufacturers have filed data with CBER to support the stability of their products at somewhat elevated temperatures and related duration of storage; they may consult with CBER concerning the impact of temperature/time duration on product stability.
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.
The FDA is aware of at least four cases in Texas in which children received emergency care due to worsening illnesses after being given products that the parents may have believed contained antimicrobials. These products were packaged to resemble antimicrobial drugs that are readily available in Mexico. It was determined the children had been given a product, Amoxilina, which the parents may have believed was the antimicrobial Amoxicillin. Giving the product to the children delayed legitimate medical treatment.
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