June 18, 2003
Recall Update: Additional Counterfeit Lipitor Quantities
The Food and Drug Administration (FDA) said that the 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
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.