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FDA warns of bacteria-laced fake drug
WASHINGTON (CNN) -- Health care providers and consumers are being warned to look for a counterfeit version of the anti-anemia drug Procrit. The fake drug, tainted with bacteria, could have serious consequences, the Food and Drug Administration said Tuesday. Procrit, chemically known as epoetin alfa, is used to stimulate the bone marrow's production of red blood cells. It's used to treat severe anemia in patients with cancer, HIV, and other chronic diseases. The fake drug is contaminated with bacteria and poses a serious hazard to patients, the FDA said, adding that testing showed it appears as a clear liquid that contains no active ingredient. FDA investigators have identified three batches of the counterfeit drug with the following lot numbers: P007645, expiration October 2004; P004677, expiration February 2004; P004839, expiration February 2004. According to Procrit's manufacturer, Ortho Biotech Products, there are subtle differences on the packaging and vials that can help consumers identify the counterfeit product. The authentic product has a carton closure seal that, when removed, leaves a visible mark on the package. The authentic seal has "OBPLP VOID" printed on its underside and is visible when removed. The fake product seals leave no visible mark when removed and have no printing on the underside of the seal. Ortho is asking that doctors, pharmacists, nurses and all other health care professionals carefully examine all Procrit packaging and vials before use. Anyone who finds vials of counterfeit Procrit should quarantine them and immediately contact the FDA's Center for Biologics Evaluation and Research at 1-800-835-4709, or Ortho Biotech at 1-800-325-7504.
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