The FDA announced Nov. 6 that at their request, U.S. marshals seized 11 lots of heparin, the injectable drug used to prevent blood clotting. The lots, at Celsus Laboratories in Cincinnati, Ohio, were intended to be used in two separate applications:
- In finished drug products (five of the lots/heparin sodium active pharmaceutical ingredient), and
- In medical devices (six lots, in the form of heparin lithium)
Contaminant from China Is Possible
The heparin at Celsus was apparently contaminated with OSCS (oversulfated chondroitin sulfate). The contaminant traced to heparin produced in China. OSCS has been confirmed to be the cause of thousands of adverse reactions, including:
- severe drop in blood pressure
- nausea
- vomiting
- shortness of breath
Problems with Products from China
The FDA has also confirmed a number of OSCS-related deaths. Chinese companies produced heparin with OSCS allegedly to save money/make a profit. Heparin is one of an increasing number of products imported from China that have been found to have dangerous manufacturing or processing flaws, some of which could not be mere mistakes.
Celsus Quarantined Its Heparin
The president of Celsus, Case Van Gorp, said that when the company learned about the possible contamination of the heparin in March 2008, they voluntarily quarantined the heparin and notified their customers of the risk. The FDA inspected their facilities in April and May, and Van Gorp stated that since that time, no OSCS had been identified in Celsus products.
However, an FDA spokesman said that the agency told Celsus in April/May that the company’s notification of customers was not enough to ensure an effective recall of contaminated heparin.
(Source: CNN)
If Contaminated Heparin Was Administered to You or a Loved One
If you suspect that contaminated heparin may have been administered to you or to your family member, contact us to speak with a defective drug lawyer today.
