Item 8.01 Other Events.
DUSA Pharmaceuticals, Inc. ("DUSA") has initiated a Class III recall on 3 lots
of its product, Nicomide®, due to a stability failure of the annual stability
lot. DUSA believes that there is no health risk associated with this product.
The recall is being conducted with the knowledge of the U.S. Food and Drug
Administration.
Since DUSA had stopped shipping Nicomide® at the end of June 2008, there is
minimal inventory at the wholesale level so this action is not expected to have
any material financial impact on the company. This product was manufactured by a
third-party manufacturer and DUSA intends to seek reimbursement of its eligible
costs pursuant to its supply agreement.
Except for historical information this report contains certain forward-looking
statements that involve known and unknown risk and uncertainties, which may
cause actual results to differ materially from any future results, performance
or achievements expressed or implied by the statements made. These
forward-looking statements relate to our beliefs regarding the health risks,
expectations regarding the financial impact associated with the recall, and
intentions to seek reimbursement from a third-party manufacturer. Furthermore,
the factors that may cause differing results include the regulatory process and
environment, actions or inactions of third-parties and other risks identified in
DUSA's SEC filings from time to time.
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