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FDA Talk Paper

T05-16
April 28, 2005

Media Inquiries: Brad Stone
                        301-827-6242
Consumer Inquiries: 888-INFO-FDA


Federal Authorities Seize Prescription Drugs from Distributors
FDA Advises Public to Check Web for Affected Medications

The Food and Drug Administration (FDA) and the United States Attorney for the District of Utah are announcing a series of indictments today against multiple prescription drug distributors whose illegal distribution of diverted drugs could affect the safety and efficacy of more than 40 medications purchased by consumers in over 80 pharmacies nationwide.

Diverted drugs are medications illegally bought, sold or otherwise circulated outside established distribution systems that assure their quality. Individual pharmacies may be unaware that the product they are buying from a distributor has been diverted and, therefore, may have been adversely affected by improper handling, storage, or transportation.

FDA has posted a list of the pharmacies and locations that may have received suspect drugs from these distributors at its Web site: http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html

This website will also provide a list of the specific types of drugs that were diverted, and the unauthorized distributors. Both lists will be updated as needed. Unless a drug named on the list has been purchased from a pharmacy listed as having received product from one of the listed distributors, it can be presumed to be safe and effective.

Consumers who have purchased listed drugs from the listed pharmacies distributed by the listed firms should not use them, but instead immediately notify their health care provider. Pharmacies who received drugs from any of the listed distributors are urged to check their inventories for any remaining products, stop dispensing the product, and notify any patient who may have purchased these affected drugs.

The distributors named in the indictment are PDRX, also operating under the name of Pharma Discount, located in Salt Lake City, Utah. Other drug distributors named in the indictment include Empire Pharmaceuticals in Newbury Park, California; DRX Medical, also operating under the name of Defonte Trading, located in Aberdeen, New Jersey; as well as PRNY Enterprises, AC Global, AC Healthcare, and Afro Caribbean Healthcare, all located in Floral Park, New York.

Criminal charges have only been made against the drug distributors named above and the only drugs affected were distributed through this illegal operation.

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