Recall Expanded for Cholesterol Drug

The Associated Press
Jun 17, 2003 : 8:00 pm ET

WASHINGTON -- Two pharmaceutical distributors have expanded the recall of the cholesterol drug Lipitor to include Lipitor products repackaged by a Nebraska company, pending a Food and Drug Administration probe tracking thousands of bottles of counterfeit pills.

Albers Medical Distributors Inc. of Kansas City, Mo., and H.D. Smith Wholesale Drug Co. of Springfield, Ill., are recalling all Lipitor products repacked by MED-PRO Inc. of Lexington, Neb., the FDA announced Tuesday.

Fake Lipitor could have harmful effects if taken in place of the real drug because it has not been proven effective at lowering cholesterol, although it contains the same active ingredient, atorvastatin. The FDA has not identified any harmful substances in the fake tablets, but testing continues.

The recalled bottles are marked "Repackaged by: MED-PRO Inc., Lexington, NE 68850. If consumers discover bottles with that stamp, they should not take the pills but return the product to their pharmacy, the FDA said. Patients who are unsure whether the pills they have are authentic should consult their pharmacist. Consumers can also contact the FDA at 1-888-INFO-FDA.

"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," the FDA said.

Earlier this month, the maker of the authentic Lipitor, Pfizer Inc., filed suit against Albers Medical Distributors and MED-PRO Inc. to stop the companies from selling any more fake versions of the drug. The FDA ordered Albers Medical Distributors to recall 100,000 bottles marked as Lipitor on May 23 after the fake drug was discovered on the market.