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T03-42 |
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The Food and Drug Administration (FDA) today announced that its continuing investigation of counterfeit Lipitor has resulted in Albers Medical Distributors, Inc., of Kansas City, Mo., expanding their recall to include all Lipitor products repacked by MED-PRO, Inc., of Lexington, Neb. In addition, H.D. Smith Wholesale Drug Co., of Springfield, Ill., has recalled all Lipitor products repacked by MED-PRO.
FDA is also announcing that its Forensic Chemistry Center in Cincinnati, OH, has determined that the counterfeit tablets that have been tested as of this date contain atorvastatin, the active ingredient of Lipitor. The Forensic Chemistry Center’s analysis to date has not identified any known harmful substances in the counterfeit tablets, although analytical testing continues.
Despite these results, FDA cannot assure that the counterfeit products are safe and effective. Individual tablets of this counterfeit medicine may vary significantly, even within individual lots, because the source of the atorvastatin is unknown and because there is no evidence that the tablets have been produced according to good manufacturing practices that are meant to ensure consistency from batch to batch.
Consequently, FDA’s advice to healthcare providers and consumers remains the same as when the agency issued its original alert on counterfeit Lipitor on May 23, 2003. They should check the packaging very carefully before using Lipitor. Patients who have any of the product labeled as “Repackaged by: MED-PRO, Inc.; Lexington, NE 68850” should not take it, and they should return the product to their pharmacy. Patients who are not sure whether they have the recalled product should check with their pharmacist.
FDA continues to work closely with the individual states and with health professionals, especially with pharmacists and pharmacy associations, to alert them to this counterfeit product and the recall. FDA’s MedWatch Safety Information and Adverse Event Reporting system has alerted health professionals and others to Albers’ expanded recall, and its notice is available online at http://www.fda.gov/medwatch/SAFETY/2003/lipitor2.htm.
FDA is also continuing its investigation into the source of the counterfeit Lipitor and will continue to pursue appropriate enforcement action.
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