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A pharma maker is voluntarily recalling several lots of a major heart medication. Here’s why.
A pharma maker is voluntarily recalling several lots of a major heart medication due to a carcinogenic impurity.
FDA and ScieGen Pharmaceuticals recalled antihypertensive drug irbesartan tablets in 75 mg, 150 mg, and 300 mg dosages at the consumer level. The 30-count and 90-count bottles were distributed nationwide to Westminster Pharmaceuticals and Golden State Medical Supply’s direct accounts.
ScieGen discovered the presence of an impurity, N-nitrosodiethylamine (NDEA) in irbesartan API it received from Aurobindo Pharma Limited, used to manufacture the final product.
“This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC),” ScieGen said in a statement.
However, Sciegen has not received any reports of adverse events related to the product.
Although the irbesartan tablets were manufactured by ScieGen, they are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc [GSMS].
Expiration dates range from September 2019 to May 2020.
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