Despite the FDA’s repeated efforts to clear the U.S. drug supply of hypertension drugs tainted with impurities believed to cause cancer, they keep being discovered. The most recent recall is 10 lots of losartan from Teva Pharmaceutical made with a tainted active pharmaceutical ingredient (API) from Hetero Labs.
Vivimed Life Sciences Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP
Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.
The European Medicines Agency (EMA) on Friday called on companies using certain reagents to manufacture the diabetes medicine pioglitazone to test their products and check their processes to rule out the presence of nitrosamine impurities, in particular nitrosodimethylamine (NDMA).
Legacy Pharmaceutical Packaging, Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg
To ensure patient access to the blood pressure medicine losartan, the US Food and Drug Administration (FDA) said late Wednesday that it will not object to certain manufacturers temporarily distributing losartan with one impurity above the interim acceptable intake limit until that impurity can be eliminated.
Update [3/20/2019] To ensure patient access to losartan, FDA will not object to certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated. The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
Legacy Pharmaceutical Packaging Issues Recall of Losartan Potassium Tablets, USP, 50mg Due to Trace NMBA
Camber Pharmaceuticals Voluntarily Recalls Losartan Potassium Tablets
Update on the EDQM review of CEP applications for sartan substances (4 Feb 2019)