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.
Related: FDA warns about opioid-containing supplement
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.
Related: FDA cracks down on websites selling iIllegal drugs
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.
Read more: Asthma drug mix-up may pose safety risk
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More