Company kept heparin on market during tests
[2008-3-27]
A drug company continued to market its heparin products in Canada even though it knew its supplier was implicated in a growing scandal involving tainted ingredients that have been linked to 19 deaths and hundreds of illnesses in the United States.
B. Braun Medical Inc. announced a recall of its heparin products in Canada, the United States and Australia last Friday, after tests confirmed some products were contaminated with an ingredient also found in heparin products recalled a month ago by Baxter International Inc., which is now the subject of a major U.S. investigation.
Baxter purchased the contaminated ingredients from Scientific Protein Laboratories LLC, a Wisconsin-based company that has a factory in China. B. Braun Medical also buys its heparin ingredients from SPL, but didn't issue a recall until tests confirmed the contamination, weeks after the supplier's ingredients were first called into question.
The incident is raising concerns over the timing of the recall and is prompting some medical experts to question whether drug companies should be required to pull product off the market as soon as it suspects contamination, rather than waiting for test results to confirm problems.
"If they do find out that the shipment has contaminated or potentially contaminated the product they're making, then definitely they need to do something about it," said David U, president and chief executive officer of the Institute for Safe Medication Practices Canada.
The problems involving heparin, a blood thinner made from pig intestines that is commonly used during dialysis and surgery, began in January, when Baxter announced a recall of some heparin products in the United States following reports of severe reactions.
B. Braun Medical Inc. announced a recall of its heparin products in Canada, the United States and Australia last Friday, after tests confirmed some products were contaminated with an ingredient also found in heparin products recalled a month ago by Baxter International Inc., which is now the subject of a major U.S. investigation.
Baxter purchased the contaminated ingredients from Scientific Protein Laboratories LLC, a Wisconsin-based company that has a factory in China. B. Braun Medical also buys its heparin ingredients from SPL, but didn't issue a recall until tests confirmed the contamination, weeks after the supplier's ingredients were first called into question.
The incident is raising concerns over the timing of the recall and is prompting some medical experts to question whether drug companies should be required to pull product off the market as soon as it suspects contamination, rather than waiting for test results to confirm problems.
"If they do find out that the shipment has contaminated or potentially contaminated the product they're making, then definitely they need to do something about it," said David U, president and chief executive officer of the Institute for Safe Medication Practices Canada.
The problems involving heparin, a blood thinner made from pig intestines that is commonly used during dialysis and surgery, began in January, when Baxter announced a recall of some heparin products in the United States following reports of severe reactions.
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