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Forty-three other batches of a drug for high blood pressure have been recalled due to fears that they do not contain traces of a potentially carcinogenic impurity. This is the last of a series of recalls since last July, which has peaked in recent weeks.
Legacy Pharmaceutical Packaging, LLC, announced Friday the recall of lots of Losartan USP tablets, as they could contain N-methyl-4-aminobutyric acid (NMBA) N, a potentially carcinogenic to humans. Legacy said that there was a process impurity or contaminant in an active pharmaceutical ingredient (API) manufactured by another company, Hetero Labs Limited.
The national recall involves 40 lots of 25mg, 50mg and 100mg of Losartan Tablets USP, and three packs of 50mg of prepackaged Losartan. Losartan is a prescription medication used to treat high blood pressure and congestive heart failure.
RELATED: See the 40 lots of the first reminder
RELATED: See the 3 lots of the second reminder
Legacy said to have received no reports of adverse events related to the use of this medication.
That's now at least six blood pressure drug reminders because of the potential cancer risk since Feb. 22. The FDA has stated that impurities could occur when specific chemicals and reaction conditions are present in the drug's manufacturing process (active pharmaceutical ingredients). This can also result from the reuse of materials, such as solvents.
The general advice with reminders similar to this one has been that patients continue to use the drug until they can determine an alternative with their doctor, although these two new recalls do not help them. have not specifically indicated. The FDA has generally stated that the risk of cancer is low.
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