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SafetyAlerts
May 25, 2001

Serono Issues Information on New Counterfeit Serostim® Lot

Norwell, MA (SafetyAlerts) - 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.

The company warned earlier this year of additional lots of counterfeit Serotism®.

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.

Serostim® (SEHR'-uh-stihm) is approved in the US for the treatment of AIDS wasting.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.