Baxter ($BAX) has had a series of recalls in the last year, including more than 600,000 units of saline solution that it began recalling a couple of months ago. Now the company is voluntarily recalling a significant quantity of the blood thinner heparin.
The company this month began retrieving 45,350 containers of heparin sodium and 0.9% sodium chloride injection in the company's Viaflex Plus containers, according to the most recent FDA Enforcement Report. The class II recall was initiated after the product was found to be subpotent for raw heparin.
"Baxter is not aware of any complaints or adverse events associated with the issue to date," spokesman John O'Malley said in a statement. He explained that Baxter is voluntarily recalling three lots because the concentration falls slightly below specification criteria. He said product is "not used for therapeutic purposes such as anticoagulation" but instead is used when a vascular catheter is inserted in a patient to reduce the chance for a catheter blockage or obstruction. "Although the heparin concentration falls just below the specification criteria, the lower concentration is not expected to impact the effect on vascular catheter patency," O'Malley said.
The recall of heparin is one in a steady stream of actions the Deerfield, IL-based drugmaker has taken as manufacturing issues have tripped it up. In early April, it called back three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units. A couple of weeks later it added to that with a recall of 8 more lots. The first recall was due to leaky bags and the second came after particulate was found in some bags.
Last year, the company recalled lot of a peritoneal dialysis solution after mold was found in some containers. In that case, it said there had been reports of patients having adverse reactions. A recent review of FDA data indicated that Baxter had 10 Class 1 recalls between 2013 and 2015, second only to competitor Hospira ($HSP).
But heparin, which is often used by patients on dialysis, presents special concerns for regulators. The FDA has been very sensitive to the quality of heparin in the market since 2008 when 80 patients died after being infused with heparin sold by Baxter. The FDA found the heparin was tainted with oversulfated chondroitin sulfate (OSCS) in crude heparin that came from Chinese suppliers. OSCS is a cheap filler product that saves raw heparin makers money, but which can be deadly to patients.
The episode resulted in a sea change at the FDA, which then stepped up inspections of foreign drugmakers. It also banned a long list of Chinese ingredient sellers and started having drugmakers test their raw heparin. But problems with Chinese heparin persists. Last year, the agency banned imports from Shunxin Meihua Bio-technical saying there were indications that the company was getting some of its raw materials from a supplier who is on an FDA watch list of suspect heparin suppliers.
- here's the FDA notice
Special Report: Top Class I drug recallers | Baxter International