Macleods Pharmaceutical Limited initiated a voluntary recall over Losartan Potassium and Losartan Potassium/Hydrochlorothiazide combination due to the excessive presence of N-Nitroso-N methyl-4-aminobutyric acid (NMBA).
The first Valsartan recall was announced a year ago due to the presence of similar contaminants. Following the recall, generic drug makers continue to remove various contaminated blood pressure medications from the market. The level of NMBA detected in these tablets exceeded FDA’s much less stringent interim acceptable exposure limit of 9.82 parts per million. The exposure limit was lessened due to the resulting hypertension drug shortage. The latest announcement made on June 25, has affected 32 lots in total.
Hundreds of product liability lawsuits have been filed due to side effects of recalled valsartan, losartan, and other blood pressure drugs, by individuals diagnosed with cancer. A growing number of lawsuits are pending in District Courts across the U.S. against Valsartan. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.
