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Another 32 lots of heart and blood pressure medication recalled 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.

MacLeods Pharmaceuticals Limited, which recalled one lot of heart and blood pressure medication losartan in February, recalled another 32 lots of losartan Tuesday for the same reason: an impurity that might be a carcinogen.

In February, the problem was NDEA, but now the problem is NMBA (Nitroso-N-methyl-4-aminobutyric acid). The active ingredient, made by India’s Hetero Labs Limited, is in the recalled lots above the FDA limit of 9.82 parts per million.

“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out,” the MacLeod’s-written, FDA-posted notice said.

Getting pulled from shelves are:

Losartan Potassium/Hydrochlorothiazide 100mg/25mg , lot Nos. BLM716A, 717A, 719A through 726A, 802A, 803A, 825A through 827A.

Losartan Potassium/Hydrochlorothiazide 50mg/12.5mg, lot Nos. BLK719A through 726A, 804A, 806A, 825A, 826A.

Losartan Potassium/Hydrochlorothiazide 100mg/12.5mg, lot Nos. BLL801A through 803A.

Losartan Potassium USP tablets 50mg, 90-count, lot No. BLI711A; 1,000-count, lot No. BLI710A.

They were distributed nationwide to wholesale distributors and retail stores.

As with previous recalls of losartan, valsartan or irbesartan, patients are advised to keep taking the medication until your doctor or pharmacist comes up with another course of treatment.

Anyone with questions about the recall should call Macleods at 855-926-3384 from 8 a.m. to 5 p.m., Eastern time. Questions about returning the tablets should go to Qualanex at recall@qualanex.com or 888-280-2046 from 8 a.m. to 5 p.m., Eastern time, Monday through Friday.

Macleods losartan label.jpg
A label from one of the recalled lots of Macleods losartan FDA

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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