On Thursday, the U.S. Food and Drug Administration (FDA) seized 11 lots of heparin from Celsus Laboratories Inc., in Cincinnati, Ohio.
U.S. Marshals seized five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. The agency found the products, manufactured from material imported from China, to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that imitates heparin’s blood thinning activity.
Heparin sodium, an injectable anticoagulant used to prevent blood from clotting in people who are undergoing certain medical procedures, was the focus of a major recall initiated in January after crude material from China was found to be contaminated.
Hundreds of patients suffered serious adverse events including 250 deaths in connection with the contaminated product, according to reports received by the FDA.
The FDA has initiated 13 recalls of multiple contaminated products containing heparin from several companies, to date.
In April the FDA inspected Celus Labs and found contaminated heparin in two products, according to health officials. Two pounds or more of the product was intended for use directly with patients and another 31 pounds was to be used in diagnostic test kits and medical devices.
The agency stepped in to seize the contaminated heparin products after the company failed to adequately notify customers of the product contamination.
Regulators prefer to negotiate with manufacturers to resolve disputes, drug seizures are a rare penalty for the agency. #