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FDA authorization extending use date of Baxter products due to IV solutions shortage

As part of its efforts to mitigate the disruption to the supply of IV solutions after Hurricane Helene temporarily closed its North Cove, N.C., manufacturing plant, Baxter announced that it is now authorized by the Food and Drug Administration (FDA) to extend the use date of some products to provide a 24-month expiration from the manufacture date without relabeling the products. In a letter to customers today, Baxter said the extended expiration date is based on Baxter’s submission to the FDA including container closure integrity data, container functional performance data, and an analysis of product weight loss profiles for those certain product codes.

Please see the Baxter document that contains the full list of Baxter product codes, lot/serial numbers, labeled expiration dates, and extended expiration dates. The extended expiration dates apply only to product codes manufactured prior to Sept. 30, 2024.

A replay of the Oct. 28 Department of Health and Human Services briefing on IV solutions conservation amid the disruption at Baxter’s North Carolina plant is now available. Visit AHA’s webpage for the latest information and conservation resources related to the ongoing disruption, including a podcast with Cleveland Clinic on conservation strategies and the importance of constant and targeted communication during supply chain shortages. Baxter also provides updates and resources on its website to include “Dear Healthcare Professional” letters for each Baxter product authorized for temporary importation that has arrived in the U.S.

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