January 23, 2001Serono Statement Regarding
Norwell, MA (SafetyAlerts) - Serono, Inc., in cooperation with the U.S. Food and Drug
Administration (FDA), is informing patients, physicians and distributing pharmacies about
a counterfeit version of Seronos Serostim® 6mg [somatropin (rDNA origin) for
injection]. Serostim® is approved for the treatment of AIDS wasting.
Unlike genuine Serostim® 6mg, the counterfeit
product is of unknown safety and efficacy and may pose a health risk to patients. The
counterfeit product, which is definitely not Serostim® , was neither manufactured nor
distributed by Serono.
Serono recently became aware of the existence of
the counterfeit drug. Serono has issued a "Notification of Potential Counterfeit
Product" to wholesalers, pharmacists, physicians and AIDS service organizations to
alert them, in an effort to prevent patients currently undergoing Serostim® therapy from
receiving the counterfeit product. The counterfeit product has been packaged to appear as
drug product lot number MNK612A and is readily distinguishable from authentic Serostim®
by the following features:
|Features of Counterfeit
A separate dark blue label is affixed to one end of the carton. The lot number
and expiration date are printed on the label in white lettering.
|Features of Authentic
- A dark blue box is printed directly on one end of the carton. The lot number and
expiration date are printed on the dark blue box in white lettering. (There is no label
affixed to the carton.)
- Expiration Date: "08/02"
- Label has straight cut corners
- Contains white, powdery "snow-like" substance and is sometimes stuck to the
- Expiration Date: "08/01"
- Label has slightly rounded corners
- Product is white lyophilized "cake", approximately 1/8" thick at the
bottom of the vial.
Lot #: "99h124"
Expiration Date: "08/02"
- Lot #: "99H124"
- Expiration Date: "06/02"
FDAs Office of Criminal Investigations is
actively investigating this matter. Serono is cooperating fully with federal authorities
to stop the distribution of the counterfeit product and to prosecute those responsible for
Carolyn Castel, Serono, Inc. - 781- 681-2340
Laura Bradbard, US Food and Drug
Administration - 301-827-6242.
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