UNITED STATES – Drug manufacturer Teva Pharmaceuticals USA Inc. has expanded a recall of a certain blood pressure medication due to concerns that it contains a potentially cancer-causing substance. The recall expansion was announced June 10 by Teva and published on the U.S. Food and Drug Administration website the following day.
The recall applies to Teva’s medication losartan potassium, which is indicated for treatment of hypertension, left ventricular hypertrophy in hypertensive patients, and nephropathy in certain diabetic patients. Teva initiated a voluntary recall of the drug in late April after discovering that the losartan tablets contained an impurity called N-Nitroro-N-methyl-4-aminobutyric acid (NMBA) at levels above those allowed by the FDA.
High levels of NMBA could lead to development of cancer, and the FDA only allows 9.82 ppm of the substance in medications. Teva found unsafe levels of NMBA in several lots of losartan potassium, which were sold to Golden State Medical Supply Inc. in California. Golden State Medical Supply then repackaged the tablets and sold the medication to retailers.
Affected medications include the following:
- Losartan potassium 50 mg – The tablets are green in color and coated in a film. They are oval with “LK 50” imprinted on one side and the “>” symbol imprinted on the other.
- Losartan potassium 100 mg – The tablets are dark green in color and coated in a film. They are oval and have “LK 100” imprinted on one side and the “>” symbol printed on the other.
The FDA says that patients taking losartan should not discontinue their medications but should contact their pharmacists or doctors about receiving another prescription. Patients may also call Teva with questions about the recall at (888) 838-2872.
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