With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.
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.
Darmerica recalls two lots of product labeled as quinacrine, a compound used as a sclerosing agent, which were instead found to contain a treatment for malaria.
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.
Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
Novartis initiates a recall of Promacta after its contract manufacturer introduced peanut flour into the same facility as the treatment, potentially causing cross-contamination.
Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
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 voluntary recall, originally initiated due to a product compliant in October 2018 for mislabeling, continues for anti-seizure drug, Levetiracetam injection in single-dose bags.
FDA provided an update on its valsartan contamination investigation and suggested it had discovered two possible causes of the carcinogenic impurities.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
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.
The latest regulatory update in the valsartan recall saga comes from the US FDA, which has published Form 483s relating to inspections at Zhejiang Huahai plants in 2016 and 2017.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
