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U.S. Department of Health and Human Services

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Serostim [somatropin (rDNA origin) for injection] Press Release Jan 2001

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

 


This is a press release from Serono, Inc. Contact the company for a copy of any referenced enclosures.


SERONO STATEMENT REGARDING COUNTERFEIT SEROSTIM®

Norwell, MA, January 22, 2001 — 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 Serono’s 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 lot #MNK612A

7-Pack Box:

  • Expiration Date: "08/02"
  • 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 lot #MNK612A

 

  • Expiration Date: "08/01"
  • 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.)

Serostim® Vial:

  • Expiration Date: "08/02"
  • Label has straight cut corners
  • Contains white, powdery "snow-like" substance and is sometimes stuck to the stopper.

 

  • Expiration Date: "08/01"
  • Label has slightly rounded corners
  • Product is white lyophilized "cake", approximately 1/8" thick at the bottom of the vial.

Diluent Vial:

  • Lot #: "99h124"
  • Expiration Date: "08/02"

 

  • Lot #: "99H124"
  • Expiration Date: "06/02"

FDA’s 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 it.

 

CONTACT:

Carolyn Castel, Serono, Inc. - 781- 681-2340

Laura Bradbard, US Food and Drug Administration - 301-827-6242