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FDA Initiates Seizure of Potentially Dangerous Drugs From Repackager

The Food and Drug Administration (FDA) today announced the seizure of all drug products labeled in a foreign language and/or labeled as repacked by Alliance Wholesale Distributors and/or Local Repack, Inc., Richton Park, Ill.

FDA acted to prevent these drug products from entering the U.S. drug distribution system because there is no assurance that they are safe or effective. Many of the products received and repackaged at Local Repack are of unknown origin, and their storage and handling is unverifiable.

“The FDA sets a gold standard when it comes to the safety of our drug supply, and we intend to protect American consumers by keeping it that way,” said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "We will take action against those who put patients at risk by trying to import and sell unapproved, mislabeled and counterfeit drugs. The haphazard and careless handling of these products, which include many drugs of dubious origin, has no place in the American pharmaceutical distribution system.”

Local Repack has repeatedly failed to comply with current good manufacturing practice (cGMP) requirements. Many drugs at Local Repack's facility are misbranded. These drugs may also pose a serious or even life-threatening risk to patients using them.

FDA inspections after an August 1999 warning letter to Local Repack revealed significant and continuing violations. The most recent inspections, conducted from February 20 through March 20, 2003, and June 16, 2003, as well as other recent information available to FDA, revealed numerous deficiencies, including:

• Local Repack failed to reveal customer complaints to FDA during inspections, including complaints where the label of the repackaged product did not match the actual contents of the package (e.g., the company failed to report its recall of product labeled 2mg Coumadin even though the product was actually 6mg Coumadin);
• Repeated instances where repackaging records were purportedly signed by a quality control employee on dates he had indicated to FDA personnel were his regular days off;
• Quality control records indicating review and approval of repackaging operations were signed before the operations were even completed;
• Incomplete or missing repackaging records, i.e., the company did not document repackaging operations for approximately 25% of its orders;
• Duplicate and inconsistent repackaging records for the same batch;
• Lack of accounting for both labels and product used in repackaging (e.g., in one instance there was no record as to the disposition of more than 5,000 Celebrex 200mg capsules received by Local Repack);
• Unreliable receiving and distribution records for drug products;
• Lot numbers on raw goods not matching lot numbers on records for final repackaged products;
• Failure to document lot numbers shipped, making it impossible to conduct a recall for specific lots of product;
• Numerous empty plastic 5,000 count containers labeled as Lipitor 10mg tablets (in Portuguese) and Lipitor 20mg tablets (in Spanish). None of the bottles or labels were the authentic manufacturer's packaging or labeling for US or foreign markets;
• Numerous empty boxes of blister-packs of Lipitor, Celebra (Brazilian version of Pfizer’s Celebrex) and Zyprexa labeled in Portuguese; and
• Inadequate label control – loose labels for various products lying around the product area where other drugs were being repackaged, creating the danger that mislabeled products would be shipped.

Today’s seizure action follows the July 9, 2003, seizure of more than 4,500 bottles of prescription drugs that were being repackaged by Local Repack stemming from an investigation of counterfeit Lipitor.

The bottles ranged in size from 5,000 and 10,000 count bottles of bulk product with foreign language labels to 90 count bottles of foreign product that had been repacked and labeled in English for sale to pharmacies across the U.S.

Many of the products seized in July were marked with expiration dates that would have allowed them to be sold after similar U.S.-approved drugs would have already expired. For example, Portuguese-labeled product that Local Repack labeled as Lipitor had expiration dates well beyond the two-year limit that is based on stability studies performed as part of the New Drug Application (NDA) approved in the U.S. for Lipitor. None of these products had been shipped to Local Repack in authentic, original manufacturer’s packaging or labeling.

Patrick Fitzgerald, United States Attorney for the Northern District of Illinois, filed the formal Complaint today in the United States District Court for the Northern District of Illinois.

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