FindLaw Class Action and Mass Tort Center: Recalls: Food, Drugs and Medical Devices: Serono Issues Notification of Counterfeit Serostim
NEWS: U.S. Department of Health andHuman Services
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Serono Issues Notification of Counterfeit Serostim®
NEWS RELEASE
Contact: Carolyn Castel
781-681-2340
For Immediate Release
Serono Issues Notification of Counterfeit Serostim®
Rockland, MA - May 16, 2002 -- 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.
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