FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

It’s back, we are still not rid of the contaminated drug it appears from this FDA press release and the products were from China.

The FDA has also sent notifications out to other countries as well.  Interestingly enough, the company’s website domain name is :  http://www.heparin.com/ 

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. 

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01912.html

 

In a related story, why did the FDA wait so long on the recall of syringes? if someone could have received twice the dosage due to mislabeled products, insulin, for diabetics.  BD

“Well, here is my question:  If one's use of the mislabeled ReliOn syringes possibly containing more than two times the intended dose of insulin could l”ad to serious side effects such as hypoglycemia and even death, why was there a four-week delay by the FDA in getting more attention directed to this syringe recall?”

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