Health Care

Another addition to recall of heart and blood pressure meds for possible carcinogen

How FDA drug recalls work

The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.
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The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.

In a domino recall after Torrent Pharmaceuticals pulled 104 lots of losartan for NMBA presence, Legacy Pharmaceutical Packaging added one lot to its recall of the heart and blood pressure medication.

Legacy’s losartan was made by Torrent. Legacy then sold it to Kroger, Co., the nation’s largest supermarket chain, for sale in Kroger, Ralphs, City Market, Dillons, Fred Meyer, Fry’s, King Soopers, QFC, Harris Teeter and Smith’s Food and Drug.

With the three lots recalled in March, Legacy has now recalled 30-count bottles of 50mg tablets with lot Nos. 180190, 180191, 181597 and 181598. The expiration date on the first two lots is 10/2020 and 2/2021 on the second two lots.

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NMBA, N-Methylnitrosobutyric acid, is an impurity considered a possible carcinogen. It’s been found in amounts the FDA considers unsafe in losartan’s active ingredient made for several companies by Hetero Labs Limited.

The FDA reminds those with recalled losartan, valsartan or irbesartan to decide with a doctor or pharmacist on another treatment course before ditching the recalled medication.

Consumers with questions can call 1-877-538-8443, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.

The FDA’s list, updated to April 18, on losartan recalled for NDEA, NMBA or NDMA presence can be found by clicking here.

The FDA’s list, updated to April 11, on valsartan recalled for NDEA, NMBA or NDMA presence can be found by clicking here.

The FDA’s list, updated to April 11, on irbesartan recalled for NDEA, NMBA or NDMA presence can be found by clicking here.

Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.


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