Torrent announces that it will recall batches of losartan tablets for the sixth time, after the detection of NMBA exceeding acceptable daily intake levels in latest recall.
After 2018 saw numerous sartan drugs recalled for possible carcinogenic impurities, in 2019, the industry kept an eye on the regulatory issues that followed and the breakthroughs that have mitigated some of the risks.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
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.
Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.
The European Medicines Agency has unearthed a ‘sartan’ medication, in losartan, that contains low levels of the carcinogenic substance, N-nitrosodiethylamine.
The FDA has announced that a lot of montelukast sodium tablets has been discovered to contain a different type of medicine, potentially posing health risks.