January 19, 2019

Torrent expands recall of Losartan caused by NDEA presence

06 January 2019, 04:43 | Rodolfo Wallace

Click to enlarge These are the drugs from Actavis Group that have been recalled

Click to enlarge These are the drugs from Actavis Group that have been recalled

A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancer-causing impurity, according to the U.S. Food and Drug Administration.

Alternative treatment options, as advised by an expert, may involve opting for a different manufacturer or switching to another blood pressure drug.

Six blood pressure medications have been recalled since November.

The impurity in the product is N-nitrosodiethylamine (NDEA), a substance that naturally occurs in some food, drinking water, air pollution and industrial processes.

It said Mylan Pharmaceuticals "is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by" by Mylan Inc.

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If your medication has been affected by the recall, contact a health care professional for further information.

Torrent is only recalling the lots of Losartan potassium tablets USP that contain NDEA levels higher than the FDA's guideline. Anyone with questions about returning the drugs can call Qualanex at 1-888-280-2040 at any time, but will speak to a live person from 8 9 p.m., Eastern time.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

A list of losartan medications under recall can be accessed via the FDA's website (pdf). The agency stresses that not all valsartan and related products are under recall, only specific lots. However, patients should consult with their pharmacist or physician who can advise them on alternative treatments. Torrent is recalling only these particular losartan potassium tablets.

"The conditions the medication treat - heart failure and high blood pressure - are serious, and patients could be harmed if they suddenly stop taking it without a replacement prescription", Dr. Steinbaum added.

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