FDA extends expiration date of some EpiPens to combat shortage

[August 21, 2018]  The Federal Drug Administration has just extended the expiration day of specific batches of EpiPens in order to combat the current shortage. On Aug. 21, 2018, the FDA alerted healthcare professionals and patients of the batches and dates through which some EpiPens and an authorized generic version (manufactured by Pfizer’s Meridian Medical Technologies) can be used beyond the manufacturer’s labeled expiration date. For safety reasons, these are for products that should have been stored as labeled and should continue to be stored according to the label.

“Based on stability data provided by Pfizer and reviewed by FDA, the following extended use dates are supported for specific batches indicated in the tables,” the FDA noted in a press release. “Patients that have the batch numbers below will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.”

Click or tap on this link for specific batch numbers and to see the full FDA brief on the extension. Contact CDER Drug Shortage Staff  drugshortages@fda.hhs.gov with questions regarding these tables.

FDA is not requiring or recommending that the identified batches in the tables be relabeled with their new use dates, but if a product does become available during the extension period, then it is possible these batches will be replaced with the new product.

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