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Company Warns of Counterfeit Serostim

Cheryl A. Thompson

Serono Inc. announced yesterday that counterfeit Serostim, also known as somatropin, has entered the market.

The counterfeit product, bearing lot number MNK612A, differs from the authentic product in four ways:

Expiration date on carton and drug vials. The counterfeit carton and drug vials have an expiration date of "08/02"; the authentic carton and drug vials have an expiration date of "08/01."

Label on carton. The counterfeit product has a dark blue label affixed to one end of the carton; the authentic product has the information printed directly on the carton.

Label on drug vials. The counterfeit drug vials' label has straight-cut corners; the authentic drug vials' label has slightly rounded corners. 

Lot number and expiration date on diluent vials. The counterfeit diluent vials bear the lot number 99h124 and the expiration date "08/02"; the authentic diluent vials bear the lot number 99H124 and the expiration date "06/02."

The company said it has issued a "Notification of Potential Counterfeit Product" to pharmacists, wholesalers, physicians, and AIDS service organizations.

Serostim is used to treat AIDS-related wasting or cachexia.

For more information, contact Carolyn Castel at Serono (781-681-2340) or Laura Bradbard at the Food and Drug Administration (301-827-6242).