Lingering heparin contamination prompts another US recall

B. Braun Medical has initiated another recall of heparin products after "additional testing" uncovered potential contamination of the active pharmaceutical ingredient with oversulphated chondroitin sulphate (OSCS).

B. Braun was one of the companies forced to recall heparin products contaminated with OSCS in the infamous 2008 case which led to more than 80 deaths in the US alone.

That earlier recall - as well as this latest one - relate to API supplied by Scientific Protein Laboratories and used to manufacture heparin products by the drugmaker in 2008.

SPL is already under scrutiny by the US Food and Drug Administration for not following up a customer complaint about OSCS contamination in October 2008 until almost a year later, according to a document posted recently on the agency's website.

An investigation into the 2008 contamination incident indicated that SPL had sourced heparin from China which was contaminated with OSCS, a cheaper substance that can mimic heparin in identity testing but can cause serious allergic reactions.

The incident is believed to be a case of economically-motivated adulteration (EMA) - a hot topic among medicine regulatory authorities in which ingredients are deliberately adulterated to fool lab testing and increase their value.

The FDA believes the heparin API was laced with cheaper OSCS to fool quality control labs, as the contaminant was indistinguishable from heparin using the standard identity testing recommended at the time. In 2008 a swine shortage in Asia made pig intestines - the raw material from which heparin is extracted - scarce.

B. Braun's 2008 recall involved 23 lots of heparin sodium formulated in 5% dextrose and 0.9% sodium chloride, and the latest recall includes seven additional lots manufactured in 2008 and with expiry dates of October 31, 2010 and November 30, 2010.

"Additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of OSCS contaminant," said the drugmaker in a statement.

As well as the FDA probe, SPL is fighting a class action lawsuit which claims it was negligent because it did not do enough to check the quality of the contaminated active pharmaceutical ingredient that ended up in heparin products distributed to patients. The suit cites another heparin manufacturer, Baxter International, as a co-defendant.


Related articles:

FDA faults heparin supplier's handling of tainted batch

Twists and turns in Baxter's heparin lawsuit

Two more Chinese companies linked to tainted heparin

FDA finds fake heparin ingredient