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 Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More