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US heparin manufacturer ordered to turn over contaminated batches of heparin. Just how much of the tainted chemical is on the market?
FDA, last week, announced that it seized 11 lots of the blood-thinner heparin from Cincinnati-based Celsus Laboratories due to possible contamination.
According to the FDA release, US Marshals seized five lots of heparin sodium active pharmaceutical ingredient and six lots of heparin lithium that the agency deemed tainted with over-sulfated chondroitin sulfate-the same foreign substance found in Chinese labs earlier this year. According to Celsus, the lots had been held under quarantine in its facility since spring, when the company instituted new tests recommended by FDA in the wake of the Chinese heparin incident, and identified problems in the lots, which were reportedly imported before the new testing standards took effect.
“This action will help prevent this contaminated heparin from finding its way into the marketplace," stated Mike Chappell, acting associate commissioner for regulatory affairs, FDA.
In a statement, Celsus said that its heparin is not sold directly to patients, and is intended only for research, purchase by a drugmaker as a component for further manufacturing, or for use in medical devices such as blood collection tubes. Celsus notified its customers about the contamination, but FDA said that the company did not do an adequate job getting the heparin back from customers. In the release, FDA noted that “the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.”
“They were old lots identified back in March, and FDA was notified by us…voluntarily,” a Celsus employee told Pharm Exec on Monday. When pressed as to why FDA felt the Celsus’s recall was not good enough, the employee refused to comment further.
In the statement, Celsus noted that FDA had checked the suspect lots in May, June, and September before finally seizing them on November 6. FDA did not return calls requesting an explanation as to why the lots weren’t seized in the first place.
Over the past year, feds have initiated 13 recalls of tainted medical products found to contain bad heparin. In February, Baxter Healthcare temporarily halted manufacturing on multi-dose vials of its heparin after severe side effects-including allergic reactions and death-were reported by patients using large quantities of the anticoagulant.
The investigation eventually led to a Chinese manufacturing plant, where it was discovered that a key ingredient in heparin had been replaced with over-sulfated chrondroitin sulfate-a man-made chemical used in place of the anti-clotting ingredient. When taken by patients, the modified drug can cause major side effects, including seizures and death.