Drug recalls following the detection of NDMA (N-nitrosodimethylamine) impurities in nizatidine drugs, which began in 2019, are still ongoing, officials say.
The Ministry of Food and Drug Safety (MFDS) recently announced the recall of Vivozon Pharmaceutical’s alzatine cap. 150mg.
The order is a precautionary measure based on the results of the product stability test.
In addition to recent recall actions, the ministry ordered the recall of two similar items in January – Medica Korea’s Zatidine 150mg capsule and Hutecs Korea Pharmaceutical’s Acitidine capsule – as a precaution following the detection of NDMA due to the test. of stability.
The recall of nizatidine products continued steadily after researchers suggested the possibility of detecting impurities for nizatidine products after the ministry detected NDMA in ranitidine in 2019, which triggered the wave of fear of impurities among Korean pharmaceutical companies.
The ministry recalled 13 items with a slight excess of NDMA among nizatidine products in the same year.
Ultimately, the food and drug regulator asked drug companies to assess and test for the possibility of contamination with nitrosamine impurities such as NDMA.
Last year, the ministry received the evaluation and test results for possible impurities in raw materials and finished products from drug manufacturers, stressing that it will review the submitted test results and take action. needed, reaffirming its concerns about NDMA and issuing nine recalls out of 15 articles. just in 2021.
Industry insiders expected that recall actions due to NDMA concerns for nizatidine may continue, as nizatidine preparations have a high frequency of NDMA due to the chemical structure of the component. . The Ministry of Food and Drug Safety also announced that it would carry out NDMA impurity testing for each manufacturing unit for pharmaceutical companies that did not submit test results assessing the possibility of impurities in May. last.
Meanwhile, the Ministry of Health and Welfare discussed measures related to impurity detection drugs and plans at the 27th Health Insurance Policy Deliberation Committee in December to compel pharmaceutical companies to cover the costs of re-prescribing and redistributing the drugs incurred by the detection of impurities.
Based on the outcome of the meeting, the Ministry of Health and Welfare demanded public service charges on 108 pharmaceutical companies from January.
The charge aims to recover the costs incurred to re-prescribe and redistribute drugs containing impurities – ranitidine, nizatidine, metformin – detected since 2019. According to the Ministry of Health and Social Care, the total charge is 2.9 billion won ($2.4 million). ).