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FDA uncovers more fake Lipitor
« on: Jun 4th, 2003, 10:32am » |
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FDA uncovers more fake Lipitor
Tuesday, June 3, 2003 Posted: 5:31 PM EDT (2131 GMT)
WASHINGTON (AP) -- Federal investigators discovered more than 30,000 additional bottles of fake Lipitor, a top-selling anti-cholesterol pill, as they worked Tuesday to crack a huge case of medical counterfeiting.
Also Tuesday, the manufacturer of real Lipitor, Pfizer Inc., filed suit to stop a pharmaceutical repackaging company and distributor from selling any more fake pills -- and to get more information to track the counterfeit's source.
Repackager Med-Pro Inc. and Albers Medical Distributors both denied involvement in the counterfeiting.
The Food and Drug Administration first uncovered three batches of fake Lipitor almost two weeks ago, and ordered Kansas City-based Albers to recall 100,000 bottles. Tuesday, the FDA announced it had turned up three more batches containing counterfeit pills.
The FDA warned Lipitor users and pharmacists Tuesday to carefully check their bottles before using Lipitor. To spot the fake version, look for the words "Repackaged by MED-PRO Inc., Lexington, NE 68850" on 90-tablet bottles that bear any of the following lot numbers:
• 20842V, expiration 09-2004
• 16092V, expiration 07-2004
• 20722V, expiration 09-2004
• 04132V, expiration 01-2004
• 16942V, expiration 09-2004
• D270481, expiration not available.
All but that last batch are 10-milligram tablets; the last one includes 20-milligram tablets.
Many patients taking Lipitor buy it in smaller quantities dispensed in different bottles by their local drugstore. So patients not sure if they have the counterfeit version should call their pharmacist, who can check the pills' source, the FDA advised.
"We want consumers, if there's any doubt at all, to call their pharmacist," said FDA Associate Commissioner John Taylor.
Pfizer says the fake Lipitor pills bear a close resemblance to real Lipitor, although they may be slightly thicker. Consumers have reported that the fake pills dissolve faster and have a slightly bitter taste. In fact, a handful of consumer complaints about the taste prompted the FDA's probe.
Drug manufacturers typically sell their products to a wholesaler that can in turn send tablets directly to pharmacies, or to a distributor and repackager before they arrive at drugstores.
Pfizer sued Med-Pro and Albers on Tuesday, saying it has no relationship with either of the companies so far identified as handling the fake pills.
"We're suing to get the product off the market and to identify the source," said Pfizer spokeswoman Vanessa McGowan.
Both Med-Pro and Albers denied involvement.
"Med-Pro acted at all times in good faith and was never knowingly involved in counterfeit Lipitor," said company attorney J.R. Hobbs.
Albers attorney Kathy Dean said the fake pills never came to the distributor's warehouse but were directly shipped from Med-Pro to a small number of wholesalers.
"We are cooperating fully with the FDA and are willing to work with Pfizer to identify the true source of the counterfeit product," she said.
Counterfeit medicine is increasingly turning up in the United States. In the last year, the FDA has investigated more than half a dozen cases. Just last month, three men were charged in Miami with a counterfeiting scheme that sold bacteria-tainted water in the guise of the anti-anemia medicine Procrit.
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