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The FDA has announced that the recall of drugs used to treat high blood pressure has been extended again.
According to the recall issued Wednesday, Legacy Pharmaceutical Packaging, LLC has extended the recall of 3 repacked batches of Losartan Tablets USP 50 mg to an additional batch. This recall was motivated by the fact that Torrent Pharmaceuticals LTD has issued a voluntary national booster of losartan tablets, USP, due to the detection of trace traces of N-Nitroso N-methyl-4-amino butyric acid (NMBA), impurity of treatment or contaminant in active pharmaceutical ingredient, 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 used to treat high blood pressure and congestive heart failure. It is presented in bottles of 30 tablets.
The NDC identification number associated with the Legacy product is: Losartan Potassium, USP, 50 mg NDC 68645-494-54
The assigned Losartan Potassium includes 4 reconditioned lot numbers.
For more information, click here.
The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain valsartan, losartan or irbesartan and are used in hypertensive patients and other conditions.
Since July, separate drugs for the treatment of high blood pressure and heart failure of ARB from different companies have been recalled worldwide, including in the United States. United, because of the presence of similar impurities potentially carcinogenic to humans.
Here is the complete list of the recalled medications.
Coverage continues here.
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