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Extension of Shelf Life Provided by Baxter Healthcare Corporation to Assist with IV Solution Shortages

25 Jan 2018 6:53 PM | AIMHI Admin (Administrator)

Due to the ongoing critical shortage of IV solutions used in critical care, FDA is alerting health care professionals of extension of shelf life through which some of these products, manufactured by Baxter Healthcare Corporation, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

FDA is not requiring or recommending that the identified product codes in the following TABLE 1 be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then it is expected that the product codes in these tables will be replaced and properly disposed of as soon as possible.

Health care professionals are instructed to squeeze the bags prior to use for verification of no leaks. If leaks are found the bags are not to be used.

Based on data provided by Baxter Healthcare Corporation and reviewed by FDA, the following extended shelf life is supported for only the product codes indicated in TABLE 1 below for the following products.

Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov  with questions regarding this table.

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