May 25, 2001
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.