Irbesartan, IABP, INR test strips recalled

The FDA issued alerts about recalls of irbesartan lots, an intra-aortic balloon pump and test strips used with systems to measure INR levels in patients taking warfarin.

Irbesartan recall

According to one alert, Aurobindo Pharma Limited recalled 22 batches of irbesartan, an angiotensin receptor blocker, due to detection of an impurity, N-nitrosodiethylamine (NDEA), which is classified as a probable human carcinogen.

The FDA stated that Aurobindo has contacted its U.S. distributor, ScieGen Pharmaceuticals Inc., to arrange return of the affected batches, and requested ScieGen to contact its distributors and retailers.

According to the agency, patients should continue taking irbesartan and contact their physician if they experience any symptoms that may be related to taking the drug.

As Cardiology Today previously reported, NDEA was also detected in several drug products with the active ingredient valsartan, another angiotensin receptor blocker.

IABP alert

According to another alert, the agency is investigating reports of Maquet/Datascope intra-aortic balloon pump (IABP) devices manufactured by Getinge shutting down while running on battery power.

The devices were already under recall, categorized as class I by the agency in September, due to reports of malfunction when used at high altitude.

In the new alert, the FDA stated it received more than 75 reports of the device shutting down while running on battery, which can lead to stoppage of the pump and loss of hemodynamic support. According to the alert, three deaths were described in five of the reports, but “they cannot be definitively attributed to the device shutting down.”

The FDA recommended that users follow all information related to care of batteries in the device’s instruction manual, plug the device into an AC outlet during use whenever possible, plug the device into an AC outlet when not in use to keep the batteries fully charged, make sure the battery is fully charged before portable operation and periodically check battery run time and replace batteries.

INR test strip recall

The agency announced that Roche Diagnostics recalled test strips used with its test meters due to inaccurate INR results in patients taking warfarin.

According to the alert, Roche recalibrated the test strips (CoaguChek XS PT) in January to conform to a new INR standard, but since then received reports that some patients experienced abnormally high or inaccurate INR results.

The recall affects more than 1.1 million packages manufactured between Jan. 12 and Oct. 29, 2018.

The alert stated that patients and providers should switch back to the test strips calibrated to the previous standard, and patients should contact their providers to investigate alternative test methods.