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MARKET INTEL by PharmaCompass
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By PharmaCompass
2019-01-10
Impressions: 284 Article
The sartan saga of last year continued well into the New Year. The USFDA put up an update on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan.
Torrent expanded its voluntary recall to include eight additional lots of losartan potassium tablets, for a total of 10 lots. This recall is due to trace amounts of N-Nitrosodiethylamine (NDEA) in the losartan API manufactured by Hetero Labs Limited.
FDA also alerted patients and healthcare professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of NDEA in the valsartan API. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.
The recall also affected a drug company based in Taiwan. Taiwan’s FDA said it was taking 3.22 million tablets of the blood pressure drug Cosar off shelves due to the potential presence of NDEA.
The Chiayi-based manufacturer of the Cosar FC Tablets 50 mg, Shou Yuan Chemical Industries, had conducted tests on its own products and found the presence of NDEA. As a result, the company alerted the country’s FDA and launched a recall of 11 batches.
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