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Home Industry News Baxter supplier advises further heparin recall

Baxter supplier advises further heparin recall

3rd April 2008

Scientific Protein Laboratories (SPL), the firm which supplies pre-filled heparin syringes to BaxterHealthcare, has advised a further recall of the product.

Heparin products from Baxter have been linked to serious allergic reactions and the deaths of at least 19 patients, MedPage Today reports.

The US Food and Drug Administration announced this week that Covidien, who is also supplied with the compound by SPL, has recalled 32 lots of its pre-filled heparin syringes as a result of contamination with a heparin-like molecule.

SPL had earlier notified the company, formerly named Tyco Healthcare, of the risk, though there has been no reports of side effects yet noted with Covidien’s heparin products.

In the US, regulators have ordered that all finished and raw heparin must be tested for the heparin-like contaminant hypersulfated chondroitin sulfate which has been identified in crude heparin from SPL plants.

In February 2008, Baxter issued an update to its voluntary recall of recall of nine lots of heparin sodium injection 1,000 units/ml ten and 30ml multi-dose vials.

The company explained that it is conducting a “thorough investigation” to determine the reason for the increased in reported adverse events, while it had suspended its manufacturing of multi-dose vials of heparin.

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