B. Braun is recalling lots of its injectable anticoagulant, Heparin, manufactured in 2008, after finding a sample used to manufacture Heparin Sodium USP active pharmaceutical ingredients (APIs) was contaminated.
The nationwide voluntary recall comes after supplier, Scientific Protein Laboratories (SPL) warned B. Braun that additional testing of heparin samples used by the firm to manufacture the single API showed trace amounts of an oversulfated chondroitin sulphate (OSCS) contaminant.
The recall covers seven lots of Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solutions, which were manufactured in 2008 and are set to expire on October 31, 2010, and are being withdrawn to the healthcare provider level.
In a statement, the company specified, “B. Braun has not received any reports of adverse events regarding the B.Braun finished products using this API,” however this was the same statement given in 2008.
A company spokesperson has since confirmed the recalled lots do not pose any significant health risks and the recall is being carried out purely as a precautionary measure under guidance from the US Food and Drug Administration (FDA).
In March 2008, B. Braun withdrew 23 lots of its heparin products, derived from pig intestines, after the FDA found contamination in heparin stock imported from the Chinese plant, Changzhou SPL. As much as 50 per cent of the recalled heparin comprised of a cheap, substitute drug, the FDA said.
Adverse effects resulting from the contaminant included anaphylactic-like reactions, low blood pressure, difficulty breathing, nausea, vomiting, diarrhoea and abdominal pain.
B Braun was unable to respond to in-Pharmatechnologist’s request for additional information about the latest recall ahead of publication.