Covidien Recalls Syringes on Contaminant

Diversified health care products Covidien Ltd. on Friday issued a voluntary recall of its pre-filled syringes containing Heparin because some might contain a contaminant.

Covidien said its supplier, Waunakee, Wis.-based Scientific Protein Laboratories, said two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contain a heparin-like contaminant.

Covidien said it is recalling the product as a precautionary measure; no adverse events have been reported.

Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions. Last Friday, 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.

There have been similar recalls of Chinese-sourced heparin in Germany and Japan.
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.

Source : www.chron.com