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Use-by Dates Extended for Injection Drugs Amid Shortage


November 16, 2017

Citing an ongoing shortage of injectable drugs used in critical care, the US Food and Drug Administration (FDA) announced on November 9, 2017 that a number of drugs manufactured by Hospira Inc., a Pfizer company, could be used beyond the expiration date on their labels.

Extended use dates have been issued for specific lots of atropine sulfate injection, dextrose injection, epinephrine injection, and sodium bicarbonate injection. The move followed an FDA review of stability data provided by Pfizer.

“Hospitals that have the following lot numbers in stock will be able to use them through the corresponding new use dates to help with supply,” the FDA announced. “As data become available, this list can continue to expand.”

A full list of the injection drugs and lot numbers, as well as their new use-by dates, is available here.

Hospitals should continue to store the medications as labeled. The FDA is not recommending items with extended use dates be relabeled to reflect their new expiration.

“However, if replacement product becomes available during the extension period, then it is expected that the lots … will be replaced and properly disposed of as soon as possible,” the FDA directed.

Jolynn Tumolo


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