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9/16/2003

Federal Government Seizes Products From Illinois Repackager

Donna Young

The Food and Drug Administration (FDA) yesterday said federal agents had seized all drug products repackaged by Local Repack Inc. of Richton Park, Ill., and its affiliated company, Alliance Wholesale Distributors.

Local Repack, the agency said, has repeatedly failed to comply with current good manufacturing practice requirements.

"Many of the products received and repackaged at Local Repack are of unknown origin, and their storage and handling is unverifiable," FDA said in a written statement.

The agency discovered many misbranded products at the company's facility that could "pose a serious or even life-threatening risk to patients using them."

Federal agents confiscated more than 4,500 containers of misbranded products from Local Repack in July.

The July action, according to FDA, was part of a larger investigation into counterfeit Lipitor, an atorvastatin calcium product marketed by Pfizer.

Local Repack filed a lawsuit in August against FDA seeking the return of the captured products, worth $2.5 million, according to the Associated Press.

Recent FDA inspections of Local Repack facilities uncovered several violations, the agency said, including empty plastic bulk containers bearing Portuguese-language labels for Lipitor 10-mg tablets and others labeled in Spanish as Lipitor 20-mg tablets.

None of the bottles or labels was the authentic manufacturer's packaging or labeling for U.S. or foreign markets, FDA declared.

Local Repack's president, Philip Giannino, told the Chicago Sun-Times that he had been repackaging foreign drug products for 20 years.

"If you do it properly it is not illegal, but the FDA doesn't have enough people to police it and so therefore they don't want anybody doing it," the Sun-Times quoted Giannino in an article reported today.

Other violations included the company's failure to reveal customer complaints to FDA, including complaints that labels of a repackaged product did not match the actual contents of the package.

One violation FDA cited was Local Repack's failure to report its recall of packages of warfarin 6-mg tablets that had wrongly been labeled as containing 2 mg of the drug.

Inspectors also discovered that there was no distribution record of more than 5,000 200-mg celecoxib capsules received by Local Repack.

Celecoxib is marketed under the brand name Celebrex by Pfizer.

The United States Attorney for the Northern District of Illinois yesterday filed a formal complaint against Local Repack in the United States District Court for the Northern District of Illinois, according to FDA.