Heparin recall again traced to API supplier SPL

Heparin has earned special notice in pharma manufacturing circles for the devastating case of contamination that killed or sickened dozens of people in the U.S. in 2008. B. Braun Medical is shouldering the burden of that stigma on top of the problems that led to its recall last week.

Seven lots of the anticoagulant may be contaminated with trace amounts of oversulfated chondroitin sulfate, the culprit in the 2008 incident, reports the LA Times.

B. Braun was notified by its API supplier, Scientific Protein Labs, which has recalled one lot of crude heparin. The SPL recall follows post-shipping testing by the API maker. That lot was used in seven B. Braun injection products. SPL also supplied the contaminated API for the heparin in the 2008 case.

The drugmaker is working through distribution and customer channels to have the products returned.

- see the article

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