FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

May 17, 2001

Dear Doctor:

Serono, Inc. and the U.S. Food and Drug Administration (FDA) are informing distributors, pharmacies, physicians and patients of the existence of a new counterfeit lot of Serono's Serostim® 6 mg [somatropin (rDNA origin) for injection]. The counterfeit material, which is made to resemble Serostim®, bears lot number MNH605A. Any product labeled as Serostim® and carrying this lot number should be considered to be counterfeit.

Patients in possession of the counterfeit lot should return it immediately to their pharmacy for a replacement. Patients seeking additional information may also call Serono's product information line at 1-888-275-7376.

Serono is sending a "Notification of Counterfeit Product" letter to wholesale distributors, pharmacies, physicians and AIDS service organizations to alert them. The counterfeit material was neither manufactured nor distributed by Serono and is definitely not Serostim®. Therefore, it cannot be assumed that the counterfeit product is either safe or effective.

Serono is cooperating fully with the FDA in its effort to stop the distribution of the counterfeit product and to prosecute those responsible for it.

If you are concerned that one of your patients may have received the counterfeit lot, please call Serono at 1-888-275-7376.

Sincerely,

Pamela Williamson Joyce
Vice President, Regulatory Affairs
Serono, Inc.

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