AIDS TREATMENT NEWS Issue #365, May 25, 2001
John S. James,
On May 17 Serono, Inc. and the U.S. FDA warned that new counterfeit drug labeled Serostim had been found. There had been a warning of a previous case of counterfeit Serostim in January of this year. From the press release:
"Serono, Inc. and the U.S. Food and Drug Administration (FDA) are informing distributors, pharmacies, physicians and patients of the existence of a new counterfeit lot of Serono's Serostim(R) 6 mg [somatropin (rDNA origin) for injection]. The counterfeit material, which is made to resemble Serostim(R), bears lot number MNH605A. Any product labeled as Serostim(R) and carrying this lot number should be considered to be counterfeit.
"Patients in possession of the counterfeit lot should return it immediately to their pharmacy for a replacement. Patients seeking additional information may also call Serono's product information line at 1-888-275-7376.
"Serono is sending a 'Notification of Counterfeit Product' letter to wholesale distributors, pharmacies, physicians and AIDS service organizations to alert them. The counterfeit material was neither manufactured nor distributed by Serono and is definitely not Serostim(R). Therefore, it cannot be assumed that the counterfeit product is either safe or effective.
"Serono is cooperating fully with the FDA in its effort to stop the distribution of the counterfeit product and to prosecute those responsible for it.
"Serostim(R) (SEHR'-uh-stihm) is approved in the U.S. for the treatment of AIDS wasting."
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