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SafetyAlerts
May 17, 2002

Serono Issues Notification of Counterfeit Serostim®

(SafetyAlerts) -  Serono, Inc. has recently become aware of a counterfeit lot of Serono's Serostim® [somatropin (rDNA origin) for injection]. The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim® lot number. Serono has notified the appropriate regulatory and law enforcement authorities of this matter.

Preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet. However, Serono is also alerting pharmacists to the counterfeit material and recommending that they examine Serostim® prior to dispensing to ensure that the package does not bear lot number S810-1A1.

The counterfeit material was neither manufactured nor distributed by Serono. Therefore, it cannot be assumed that the counterfeit material is either safe or effective.

Serono continues to cooperate with regulatory and law enforcement authorities to identify and prosecute individuals involved in drug counterfeiting.

Serostim® is approved in the U.S. for the treatment of AIDS wasting. Patients seeking information regarding Serostim® may call Serono at 1-888-275-7376
.

 

Source: FDA

Important Note Regarding Auto Recalls
Frequently SafetyAlerts will list auto recalls before
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Did you know?
During 2001 there were over
1575 products recalled in the United
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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.