UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 8.01 Other Events.
On February 9, 2024, Biofrontera, Inc. (the “Company”) was notified that its licensor for Ameluz®, Biofrontera AG (the “Licensor”), had initiated a voluntary recall of a limited number of lots of Ameluz®, the Company’s licensed product, due to a manufacturing defect in the impacted product’s packaging, which is provided by an unaffiliated supplier. In its communication, the Licensor confirmed that the recalled product is not likely to cause adverse health consequences. The Company is in the process of notifying all impacted physician customers of this recall and arranging for the prompt replacement of the recalled products.
Pursuant to the Company’s License and Supply Agreement with the Licensor, the Company will not bear any financial responsibility for the costs associated with this recall. As such, the Company does not anticipate a material financial impact on its business as a result of the recall.
SIGNATURE
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 hereunto duly authorized.
February 13, 2024 (Date) |
Biofrontera Inc. (Registrant) | |
| By: | /s/ E. Fred Leffler III | |
| E. Fred Leffler III | ||
| Chief Financial Officer |