Teva Pharmaceuticals USA, Inc. has expanded its own voluntary consumer-level recall originally pioneered on April 25, 20-19 at the United States of losartan potassium tablets.
That is a result of the detection of an impurity — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) — that is above the US Food & Drug Administration’s interim acceptable exposure limit.
The source of the NMBA impurity was discovered in one large amount of active pharmaceutical ingredient (API), fabricated by Hetero Labs Limited, that has been found at the manufacturing of their six (6) bulk lots of those medication products.
Based on the available data, there’s a possible danger of developing cancer in a few patients after longterm usage of products containing elevated levels of NMBA.
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The influenced losartan potassium tablets being recalled are clarified as:
Patients taking losartan potassium tablets have been advised to continue taking their medication and get their pharmacist, physician, or medical provider for advice regarding another therapy.