Another US heparin recall for OSCS contamination
pharmafile | November 5, 2010 | News story | Manufacturing and Production |Â Â API, B. Braun Medical, heparin, manufacturing compliance, recallsÂ
US pharmaceutical company B. Braun Medical has initiated a recall of heparin products in the USA after another incident involving contamination of the active pharmaceutical ingredient (API).
The company announced the recall after being notified by its supplier – Scientific Protein Laboratories – that the heparin API had higher-than-permitted levels of oversulphated chondroitin sulphate (OSCSC), the same contaminant that caused dozens of deaths around the world in 2008.
Along with the likes of Baxter International, B. Braun Medical was among the suppliers which had to recall heparin products in 2008 after OSCS contamination was uncovered in API supplied by SPL.
In the 2008 recall, it emerged that SPL had sourced heparin from China which was contaminated with OSCS, a less costly substance that can mimic heparin in identity testing but can cause serious allergic reactions. It is believed this was a case of economically-motivated adulteration because at the time there was a scarcity of heparin, which is sourced from pig intestines, resulting from a swine shortage in Asia.
The latest recall applies to an additional seven finished product lots of heparin sodium formulated in 5% dextrose (two lots) and 0.9% sodium chloride (five lots) which were manufactured in 2008 and have expiry dates of 31 October, 2010 and 30 November, 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 a result, B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level,” it added.
SPL was recently cited by the FDA for failing to follow-up a customer complaint about an OSCS-contaminated batch of heparin API received in October 2008 quickly enough.
Phil Taylor
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