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FDA Expresses Concern As Third Nitrosamine Impurity Found In Certain ARB Medicines

 
• By Grace Montgomery

The FDA is “deeply concerned” after the presence of a third nitrosamine impurity is found in certain generic ARB medicines; Hetero Labs recalls 87 lots of losartan tablets after recent FDA tests show NMBA levels higher than the agency’s interim acceptable intake limits.

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FDA is concerned as third nitrosamine impurity is found in certain ARB medicines • Source: Shutterstock

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said that the agency is “deeply concerned” about the presence of a third nitrosamine impurity that has been found in certain generic angiotensin II receptor blocker (ARB) medicines.

India’s Hetero Labs has announced a recall of 87 lots of losartan potassium tablets in three strengths – 25mg, 50mg and 100mg – after recent FDA testing showed N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) levels higher than the agency’s interim acceptable intake

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