UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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CURRENT REPORT
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Item 8.01. | Other Events |
On October 19, 2023, United-Guardian, Inc. (the “Company”) informed the U.S. Food and Drug Administration (the “FDA”) of a potential supply shortage of Renacidin® Irrigation (the “Product”).
By way of background, on September 29, 2023 the Company was informed by Amsino Healthcare (USA), Inc. (“Amsino”), the successor in interest to Smiths Medical, one of its material suppliers, that Amsino was temporarily ceasing the manufacture and supply of the Product as its facility underwent required maintenance and addresses several observations made by the FDA. At the time, Amsino informed the Company that the delays would extend until early December.
On October 10, 2023, several weeks after the initial correspondence, Amsino informed the Company that it was extending the production shutdown and revised the timeline that it initially provided. As a result, Amsino currently anticipates that two outstanding purchase orders of the Product originally scheduled for December 5, 2023 and January 9, 2024 will now take place on or about February 2, 2024 and February 9, 2024, respectively.
Given the latest information, the Company has determined it will likely exceed its current supply levels of the Product prior to the delivery dates provided by Amsino in its revised timeline. In connection with the Company’s mandatory notice to the FDA regarding the shortage of the Product, the Company is taking every measure reasonably available to mitigate the impact caused by these delays.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
UNITED-GUARDIAN, INC. | ||
By: | /s/ Donna Vigilante | |
Name: | Donna Vigilante | |
Title: | President |
Date: October 25, 2023