The FDA's Assoc. Commissioner for Regulatory Affairs John Taylor visited The Early Show and said 130,000 bottles of the fake drug have been recalled.
Lipitor is a widely distributed prescription medication taken by millions to lower cholesterol. The FDA said on Tuesday that it had discovered 30,000 bottles of fake Lipitor. About two weeks ago, the FDA uncovered three batches of fake Lipitor and recalled 100,000 bottles.
Also on Tuesday, Pfizer said it began legal proceedings against two companies to halt distribution of the counterfeit Lipitor. One is Med-Pro, a Nebraska drug-packaging company, and the other is Albers Medical Distributors of Kansas City. Pfizer doesn't have any distribution relationship with Med-Pro or Albers. Both companies deny involvement in the counterfeiting.
Millions of bottles are manufactured every year for millions of patients, so the scope of the problem at this stage is relatively small. The FDA has said that they don't have any reports of adverse health effects from the counterfeit drug as yet. Some users have noted a bitter taste and a faster dissolve from the fake pills. They may also be a little thicker pill than the real thing. There are potential health ramifications from the fake pills because they do not have the intended effect of lowering cholesterol.
Pfizer Inc said it is notifying pharmacists and other healthcare professionals that drug tablets identified as Lipitor in packages prepared by Med-Pro Inc may be counterfeit.
On their Web sites, the FDA and Pfizer tell patients to look for the words "Repackaged by MED-PRO Inc., Lexington, NE 68850" on 90-tablet bottles that bear any of the following identification 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.
Taylor says if the Lipitor was dispensed in a different bottle by a local pharmacist, people should contact the pharmacist and check the source. If there's any doubt at all, call your pharmacist.