Additional Valsartan Products Recalled
January 2, 2019 – Aurobindo Pharma has announced a voluntary recall of certain valsartan-containing products following the detection of N-Nitrosodiethylamine (NDEA) above the U.S. FDA’s currently defined acceptable daily intake level of 0.083 parts per million. Valsartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure and prevent serious medical events such as heart attack or stroke.
The affected medication consists of two lots of valsartan tablets, 26 lots of amlodipine/valsartan tablets, and 52 lots of valsartan/hydrochlorothiazide (HCTZ) tablets. Full details of the recall, including lot numbers and dates of expiration, can be found at the following link:
As with previous recalls of ARB products due to NDEA impurities, patients should not stop taking their medication prior to receiving a replacement or speaking to their healthcare provider or pharmacist about switching to an alternative treatment. The risk of stopping treatment may be higher than the risk presented by NDEA exposure.
Patients who have questions regarding the recall or who wish to report an adverse event can reach Aurobindo Pharma at 1-866-850-2876 (selection Option 2) or firstname.lastname@example.org. Adverse events can also be reported to the FDA’s MedWatch program, and should be reported to the patient’s healthcare provider.
Benecard Central Fill has not been impacted by the recall.