[ad_1]
SciGen Pharmaceuticals has voluntarily recalled certain batches of the angiotensin II receptor blocker (ARB), irbesartan, due to the presence of NOT-Nitrosodiethylamine (NDEA), a probable human carcinogen, has announced the US Food and Drug Administration (FDA) in an alert for the safety of the drug.
Laboratory tests have confirmed the presence of NDEA in some lots of ScieGen irbesartan. "This is the first non-valsartan drug that the agency has discovered to contain the NDEA impurity," the FDA said.
ScieGen's recall involves approximately 1% of the drugs administered by irbesartan in the US market.
To date, SciGen has reported that it has not received any reports of adverse events related to this recall, the company said in a statement.
The recalled irbesartan tablets (USP 75, 150 and 300 mg) were manufactured by SciGen and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS). A list of recalled irbesartan products is available online.
In addition, the FDA has announced that Aurobindo Pharma Ltd., manufacturer of Active Pharmaceutical Ingredient (API) -based products from ScieGen's irbesartan, had recalled all untouched batches of its API from Irbesartan supplied to the US market with NDEA. "FDA and Aurobindo's laboratory tests have confirmed the NDEA in some batches of their irbesartan IPA," the FDA said.
The saga of contaminated "sartans" began in July, when some of the Zhejiang Huahai Pharmaceuticals (ZHP) -based valsartan products were contaminated with another potential carcinogen, NOT-Nitrosodimethylamine (NDMA). This has led US and European regulators to remove all relevant Valsartan products from the market.
In September, the FDA banned imports of API drugs and finished pharmaceutical products manufactured by ZHP, as indicated by Medscape Medical News.
The FDA has announced that it continues to test for the presence of impurities in all AROs and has published two methods to allow manufacturers and regulatory agencies around the world to test their ARA for unexpected impurities. NDMA and NDEA. "The combined headspace method and the combined direct injection method allow simultaneous detection and quantification of NDMA and NDEA in ARB API and finished pharmaceuticals," said Dr. # 39; agency.
Adverse reactions or quality issues associated with the use of these products should be reported to the FDA MedWatch Adverse Events Reporting Program.
For more news, join us on Facebook and Twitter
[ad_2]
Source link
