(KPLC/Gray News) - Legacy Pharmaceutical Packaging LLC. is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg due to a possible process impurity or contaminant in an active pharmaceutical ingredient, according to the FDA.
FDA says trace amounts of N-Nitroso N-Methyl 4-aminobutyric acid were detected. NMBA is a potential human carcinogen.
Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure, FDA says. Products can be returned to the dispensing pharmacy.
These products were distributed by pharmacies nationwide, says the FDA. To date, there are no reports of adverse events.
See the full report, including the full list of the affected products, here.
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