Health Care

35 more 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.

Another 35 lots of heart and blood pressure medication losartan have been recalled because of unsafe amounts of NMBA in the active ingredient.

Teva Pharmaceuticals made Losartan Potassium USP tablets in 25mg and 100mg strengths for Golden State Medical Supply, according to the Teva-written, FDA-posted recall notice. Golden State then repackages the tablets for retail sale. Golden State’s website identifies its company’s customers as mail order pharmacies, military pharmacies and governments from local to federal.

As with Torrent and Camber did in their recent losartan recalls over NMBA (Nitroso-N-methyl-4-aminobutyric acid), Teva points the finger back at Hetero Labs Limited. Teva says six lots of the losartan’s active ingredient, which came from Hetero Labs, had NMBA that exceeded the FDA’s guidelines.

“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 recall notice states.

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The FDA advises anyone with losartan, valsartan or irbesartan that’s been recalled to continue taking the medication until your doctor or pharmacist comes up with a new course of treatment. You’re more likely to be harmed in the short term by not taking necessary medication.

The 25mg tablets are light green with a teardrop shape, “LK 25” on one side and a “>” sign on the other side. The 100mg tablets are dark green, oval with “LK100” and “>” on the sides.

To check the lot numbers after Golden State Medical’s repackaging, click here.

Until last week, the FDA was keeping updated lists of recalled losartan, valsartan and irbesartan, but inexplicably have cut back to this list on a page that says it hasn’t been updated since March 13.

For customers who want to return their pills, contact Teva’s recall processor Inmar at 877-789-2065, Monday through Friday, 9 a.m. to 5 p.m., Eastern time, or email Inmar at tevarecalls@inmar.com. Golden State Medical Supply’s customers can call 800-284-8633, ext. 215, fax 805-437-7582 or email recalls@gsms.us.

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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