Prinston Pharmaceutical Inc., a reputable pharmaceutical company of US, has decided to call back its medications of eight lots which is reportedly used during heart failure or when blood pressure shots up to high levels.
The company recently decided to voluntarily recall Irbesartan HCTZ tablets in seven lots along with Irbesartan in one lot after it was identified that a pharmaceutical ingredient in sufficient amount was detected with specific unexpected impurity found in truce amount higher than the consumer level.
Of the lots of tablets being recalled by Prinston, there are only those Irbesartan products that contain N-nitrosodiethylamine or NDEA in the higher level than that of recommended by FDA. According to classification by the International Agency for Research on Cancer (IARC), NDEA comes under the category of probable human carcinogen.
Insiders from Prinston have issued a statement saying that until now they haven’t received any reports regarding adverse events caused due to the presence of NDEA in these tablets.
Many American Medical professionals use Irbesartan HCTZ along with Irbesartan to treat the heart failures and recommend these to those who have regularly have high blood pressure issues.
Prinston has issued an advisory stating that those patients who were earlier taking these tablets should contact their doctors immediately to take alternative medicines to treat their heart or blood pressure issues. Those who were put on Irbesaratan have been advised to continue it till their local pharmacist gets a replacement for this, or their doctors recommend them some alternative one.
Prinston had distributed Irbesaratan HCTZ along with Irbesaratan along across the country through the help of wholesalers, distributors, repackagers, and retail buyers to treat BP and heart issues. The company representatives have started contacting customers as well as the distributors to discontinue the sale of this medicine immediately and start sending back these specific lots to the company. They have also been told to notify their sub-accounts promptly.