Some Irbesartan tablets manufactured by ScieGen Pharmaceuticals and labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS) are impacted by the voluntary recall.
The FDA says the impacted products are being recalled due to the presence of an impurity: N-nitrosodiethylamine (NDEA). The International Agency for Research on Cancer lists the substance as a probable human carcinogen, according to the FDA.
The FDA has published a complete list of effected drug lots, which were sold in 75 mg, 150 mg, and 300 mg doses.
For patients who find their medication is among the recalled batches, the FDA recommends contacting a pharmacist or physician about alternate treatment. Patients should continue taking their medication until an alternative treatment can be arranged, as immediate discontinuation could be more harmful, the FDA says.
Oct. 26: This week's recalls: Millions of pounds of ready-to-eat food, plus Ford Focus cars and BMWs
NDEA "occurs naturally in certain foods, drinking water, air pollution, and industrial processes," the FDA says.
Irbesartan is prescribed to treat high blood pressure and can be used to treat kidney disease in some patients, according to a U.S. National Library of Medicine publication.
As of Tuesday's release, ScieGen Pharmaceuticals was not aware of any adverse events related to the recall, the FDA reported.
On Oct. 26, the FDA announced that Aurobindo Pharma Limited recalled 22 batches of Irbesartan, which were sent to ScieGen Pharmaceuticals Inc., U.S. to be manufactured into the finished Irbesartan drug.
The Irbesartan recall follows a similar one in August for the heart drug valsartan.
About the Author