After Camber Pharmaceuticals issued its voluntary nationwide recall of losartan tablets, when trace amounts of the possible carcinogen N-Nitroso N-Methyl 4-aminobutyric acid (NMBA) were found in the active pharmaceutical ingredient (API), Legacy Pharmaceutical Packaging followed suit and recalled 40 lots of its repackaged losartan tablets.
Legacy Pharmaceutical Packaging also recalled three repackaged lots of losartan tablets, after Torrent Pharmaceuticals issued a nationwide recall.
The recalled losartan tablets from both Torrent and Camber were manufactured at Hetero Labs, a pharmaceutical company based in Hyderabad, India.
Sartan recall saga
NMBA is the latest impurity to be found in sartan products, and while Camber did not receive any reports of adverse events, it issued a recall on 87 lots of its losartan tablets.
Recalls of sartan products have been ongoing, as N-nitrosodiethylamine (NDEA), NMBA, and N-nitrosodimethylamine (NDMA) have all been identified in valsartan, losartan and other products containing the API.
The European Medicines Agency (EMA) has drawn conclusions as to the cause of the impurities and is continuing to investigate the presence of NDMA and NDEA in medicines to find a way in which the contamination can be identified and avoided.
Through the investigation, the EMA identified other nitrosamines, including N-nitrosoethylisopropylamine (EIPNA), and N-nitrosodiisopropylamine (DIPNA), which could be formed during the synthesis of sartans with a tetrazole ring.
Note: Legacy Pharmaceutical Packaging is an unrelated company to Legacy Pharmaceuticals.