Bad news coming out of Canada for Apotex. Canadian regulators are informing hypertensive patients that the drugmaker is conducting a voluntary recall of one lot of Apo-Ramipril 5-mg capsules. The problem? The lot of capsules are intact, but empty, meaning patients won't receive needed medication.
The company first became aware of the the situation after an astute customer noticed and complained. The capsules aren't transparent, so it might be difficult for patients to notice they are empty. Affected products are from Lot JR2178.
As Statistics Canada notes, 17.1% of Canadians aged 12 and older reported having high blood pressure in 2010. Without appropriate treatment, hypertension may lead to heart attack, stroke, kidney problems, internal bleeding and improper blood circulation.
Word of the recall comes as Apotex seeks $520 million in damages from the U.S. government, claiming an "import alert" related to problems at two Toronto-area plants that halted shipments into the country for two years violated the North American Free Trade Agreement.
Apotex maintains its U.S. business was "devastated." Before the alert, it was the sixth-largest distributor in the U.S. By July 2011, when the alert was lifted, it had fallen to No. 25.
The company has hired a top firm to represent it, but it might face a tough road. "It's going to be a bit of an uphill climb for them," said Luke Peterson, publisher and editor of Investment Arbitration Reporter, as quoted by The Toronto Star. "The U.S. is going to respond and say this is about trade. This is not about you making an investment in the States."
- check out the Health Canada release
- here's the updated and corrected release (features correct lot number)
- get more from The Toronto Star