A third blood pressure drug has been recalled over a carcinogenic impurity, the FDA announced Nov. 8.
Sandoz voluntarily recalled one lot of its losartan potassium hydrochlorothiazide tablets after they were found to contain a trace amount of N-nitrosodiethylamine (NDEA), which has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
The pills were shipped nationwide to distributors on or after Oct. 8, according to the announcement. The affected products include 100 mg and 25 mg tablets sold in 1,000-count plastic bottles with the lot number JB8912.
Sandoz said it notified distributors of the problem via overnight mail and recommends patients continue taking the drugs until a replacement can be found, “as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.” No adverse events related to the contaminated lot were reported before the recall announcement was issued.
Losartan potassium hydrochlorothiazide is the third angiotensin II receptor blocker to be recalled over the last few months due to possible cancer risk. Irbesartan was recalled on Oct. 30 because of NDEA contamination. Likewise, valsartan was recalled in dozens of countries this summer after another carcinogen, N-nitrosodimethylamine (NDMA), was detected.