The FDA has announced that a recall for medication used to treat high blood pressure has been expanded again.
According to the recall issued Wednesday, Legacy Pharmaceutical Packaging, LLC expanded its recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).
NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.
Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30 count bottles.
The identifying NDC number associated with Legacy’s product is as follows: Losartan Potassium, USP, 50mg NDC 68645-494-54
The affected Losartan Potassium includes 4 repackaged lots numbers.
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The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.
Starting in July, separate lots of ARB blood pressure and heart failure medications from various companies were recalled around the world, including in the United States, due to containing similar impurities that are potential or suspected human carcinogens.