[ad_1]
There is more fallout from the altered API losartan produced in India by Hetero Labs. A week after Torrent recalled more than 100 batches due to an impurity that could cause cancer, Teva added to the recall 25 tablets of loose losartan potassium tablets, made from the Hetero ingredient. The two recalls are likely to aggravate the losartan shortages that the FDA has already warned.
Teva, in an advertisement released by the FDA, voluntarily reminds the general public of six 25 mg batches and 29 lots of 100 mg, which she has all sold to Golden State Medical Supply. The FDA recalled that it had been recalled after the FDA had determined that six lots of hetero API contained impurities, N-nitroso-N-methyl-4-aminobutyric acid (NMBA). , which exceeded the limit of acceptable exposure.
Teva pointed out that the risk of getting cancer while taking the pills is very low and, as a result of an FDA recommendation, told consumers who own one of the tablets to continue taking them until they reach the end of their life. their doctor or pharmacy can find an alternative.
Torrent last week recalled 36 batches of losartan potassium USP tablets and 68 batches of losartan potassium / hydrochlorothiazide tablets USP in a variety of dosages due to NMBA contamination. The recall totals more than 1.07 million bottles.
RELATED: FDA declares 40 generics free of carcinogens as "sartan" recalls continue
The sartan fiasco began last year when an American drug manufacturer announced to the FDA that it had discovered N-nitrosodimethylamine (NDMA), an impurity, in an active pharmaceutical ingredient made from valsartan manufactured by the company Chinese Zhejiang Huahai Pharmaceutical. After investigation, the agency found that NDMA, NDEA and NMBA contaminants, considered as probable carcinogens, can be formed through specific and commonly used manufacturing processes.
As recalls accumulated, the FDA this month identified drugs from 40 producers whose dockage levels did not exceed acceptable levels. But the discovery of new drugs has also continued, resulting in a shortage of valsartan and losartan, drugs commonly used in the treatment of high blood pressure.
In March, the FDA acknowledged that there was a shortage of losartan and that alternatives might not be readily available. In response, the scientists estimated that the risk of stroke or heart attack due to consumers not taking their blood pressure medications was greater than their potential cancer risk. The FDA has stated that patients should continue to take the same recalled medication until their caregiver or pharmacy can find a source of impurity-free medication.
At the edge of the mess, the inevitable legal consequences have also spread. Last week, a consumer lawyer suing drug companies for manufacturing or marketing contaminated drugs told a federal judge that he was expecting some 2,000 lawsuits to be filed. of injuries caused by adulterated products in the next two years.
[ad_2]
Source link