More heparin recalled because of contamination
WASHINGTON - A manufacturer of the blood thinner heparin initiated a nationwide recall yesterday because some products may contain a potentially dangerous contaminant. Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions.
In the recall made public yesterday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with the product, company officials said.
The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, said an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally.
Federal officials are investigating how the contaminant got into the drug.
Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
Scientific Protein Laboratories also supplies Baxter International Inc. Baxter recalled nearly all its US-sold heparin injections after some patients experienced extreme allergic reactions. The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.
China's drug safety agency recently said that raw heparin suppliers have been required to improve their management and tests on their products.
