Recall of Blood Pressure Drug That Has Cancer-Causing Contaminant Widened Once Again

consumer
June 13, 2019Jun 13, 2019

The saga of blood pressure medication recall continues. Teva Pharmaceuticals has expanded its recall of blood pressure medication by discontinuing sales of certain 50 mg and 100 mg strength losartan potassium USP tablets, according to the U.S. Food and Drug Administration.

The medication is used to treat hypertension. It had already been distributed it to their customers.

Teva's recall started on April 25. It happened after the FDA detected carcinogens in an active ingredient.

The drugs listed in recall notices this week include six lots of the tablet: two lots of the 50 mg strength and four lots of the 100 mg strength.

These recall include:

  • Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and ">" on the other side.
  • Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

The cancer-causing impurity is N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The level of the contamination exceeds the FDA’s acceptable exposure limit of 9.82ppm.

Other makers of losartan have also issued recalls.

“Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment,” the FDA wrote in a notice. “The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without alternative treatment.”

Patients who wish to report a concern or have medical-related questions may contact Teva Medical Information by phone at 888-838-2872 on weekdays 9 a.m. until 5 p.m. Eastern Time. Patients also may email at druginfo@tevapharm.com.

To view the complete list of recalled losartan potassium products, click here.

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