Last year, the FDA announced a whole bunch of recalls related to blood pressure medication over fears that an impurity created during the manufacturing process could lead to cancer. The compound in question was found in dozens of prescription medications that contained the active ingredient valsartan, prompting several distributors and manufacturers to issue voluntary recalls affecting countless heart patients.
Now, additional medications containing a similar blood pressure drug, irbesartan, have been found to contain the same impurity, and a new round of recalls is upon us. Solco Healthcare LLC is now asking anyone with potentially contaminated medication to stop taking the drug.
The impurity responsible for this and many other recalls is the presence of N-Nitrosodiethylamine, or NDEA. It can be naturally occurring but it’s also a byproduct of manufacturing processes and is thought to be a human carcinogen, meaning that it likely promotes cancer.
The FDA’s bulletin on this latest recall reads as follows:
FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals (ZHP).
The FDA goes on to note that the compound NDEA was found at levels above 0.088 parts per million, which is the current limit considered safe, at least until further investigation is done into its potential negative effects.
A total of eight lots of the medication are included in the recall, in both 150mg and 300mg varieties and several different bottle sizes. You can check the lot numbers and distribution dates on the official recall page.
If you happen to have one of these prescriptions in your medicine cabinet the FDA advises that you contact your pharmacist or the prescribing doctor to be placed on a different blood pressure management drug and cease taking the recalled medication as soon as possible. A product return address is also available on the recall page.