WASHINGTON A manufacturer of the blood thinner heparin initiated a nationwide recall Friday 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 announced Friday, 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 their product, company officials said in a press release.
The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that 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 U.S.-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.
There have been similar recalls of Chinese-sourced heparin in Germany and Japan.
China's drug safety agency recently said that raw heparin suppliers have been required to improve their management and tests on their products.
Typical symptoms of the allergic reaction to heparin include low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.
Customers in the U.S. and Canada that have received heparin from one of the recalled product lots should discontinue use immediately
FDA officials said that recall would still allow for an adequate supply of heparin. The heparin that Baxter recalled primarily is used in large-dose injections just prior to surgery. While the heparin from B. Braun Medical Inc., is a pre-mix solution given intravenously, officials said.