FDA warns about dangerous fake version of Procrit (8008)

A counterfeit version of the anti-anemia drug Procrit that is frequently prescribed to HIV-positive adults poses a serious danger to patients, the government says, and hospitals and pharmacies may have unknowingly bought the fake, the Food and Drug Administration said Tuesday. The fake Procrit is useless and contaminated with bacteria, and health workers and patients should very carefully examine vials of Procrit to verify that the drug is authentic. Patients who discover counterfeit versions of the drug should not take it, the FDA urged. The federal agency identified three batches of the fake drug that bear the following lot numbers and expiration dates: P007645, expiration October 2004; P004677, expiration February 2004; and P004839, expiration February 2004.

Ortho Biotech Products, the drug's manufacturer, said consumers should check for differences on the packaging and vials. The aluminum seal on a vial of real Procrit is smooth, not dented. The closure seals on the outer carton of real Procrit have writing on the underside and leave a residue when peeled away. To help identify the dangerous counterfeit, Ortho Biotech posted pictures of the real and fake versions on its Web site, www.procrit.com.

The three fake batches, discovered by FDA investigators, consist of a clear liquid that contains no medication. The counterfeit batches also are tainted with at least two types of bacteria, which pose a risk of infection in already seriously weakened patients.

Anyone discovering a counterfeit batch of Procrit should call the FDA at (800) 835-4709 or contact Ortho Biotech at (800) 325-7504.