The FDA has announced that a recall for hypertension drugs has been re-expanded.
According to the recall released on Wednesday, Legacy Pharmaceutical Packaging, LLC expanded the recall of 3 repackaged Losartan tablets from USP 50 mg to add an additional lot. This recall was triggered because Torrent Pharmaceuticals LTD issued a voluntary nationwide recall of Losartan Tablets (USP) because traces of N-nitroso have been detected. N-methyl-4-amino-butyric acid (NMBA) is a potential process contaminant or impurity in an active agent manufactured by Hetero Labs Limited (API manufacturer).
NMBA is a potential carcinogen for humans. To date, Legacy has not received any reports of adverse events related to this recall.
Losartan Potassium USP is a prescription medication for the treatment of high blood pressure and heart failure and is packaged in 30-ton bottles.
The Identifying NDC The number associated with Legacy's product is as follows: losartan potassium, USP, 50mg NDC 68645-494-54
The affected losartan potassium contains 4 repackaged lot numbers.
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The recall is the latest in an ongoing study of a class of drugs called valsartan, losartan, or irbesartan, called angiotensin receptor blockers or ARBs, used in patients with high blood pressure and other conditions.
Starting In July, separate batches of ARB drugs for blood pressure and heart failure were withdrawn from various companies around the world, including the United States, for containing similar contaminants that are potential or suspected human carcinogens.
Here is the full list of recalled medicines.
Continuous coverage here.