Dongkuk Pharma's Nizatidine Drug Recalled Over Safety Concerns

▲A nizatidine-based drug produced by Dongkuk Pharmaceutical has been found to contain NDMA (N-nitrosodimethylamine), prompting food and drug authorities to issue a recall. / Courtesty of Dongkuk Pharmaceutical 출처 : 산경투데이(https://www.sankyungtoday.com)

 

 

 

By Park Si-soo

 

SEOUL, May 9 (Sankyung Today) -- A nizatidine-based drug produced by Dongkuk Pharmaceutical has been found to contain NDMA (N-nitrosodimethylamine), prompting food and drug authorities to issue a recall. 

 

The Ministry of Food and Drug Safety (MFDS) has announced that it has recalled some manufacturing numbers of Dongkuk's Nizatin Capsules as a precautionary measure due to the exceedance of the NDMA standard in the stability test.

 

NDMA is a 'non-intentional impurity' designated by the WHO's International Agency for Research on Cancer (IARC) as a probable human carcinogen and has been detected in hypertension drugs.

 

In 2019, the ministry collected nizatidine raw materials and 93 finished drug items on the market and tested them for NDMA, finding that NDMA was detected in trace amounts exceeding the provisional control standard (0.32 ppm) in some manufacturing numbers.

 

As a result, the government temporarily suspended the manufacture and sale of 13 pharmaceutical products that exceeded the provisional control standard for NDMA. 

 

However, since then, the recall of nizatidine has been repeated every year. In 2021, a total of 15 items were recalled, and in 2022, six items were recalled.

 

The latest recall underscores the ongoing issue with NDMA contamination in drugs. Although the amounts of NDMA detected in the recalled products are relatively low, the potential risk to public health cannot be ignored.

 

The ministry calls on consumers who have purchased the affected Nizatin Capsules to immediately stop using the product and consult their healthcare provider for an alternative medication. 

 

It has also urged healthcare providers to contact their patients who have been prescribed the affected product and advise them to switch to an alternative medication.

[저작권자ⓒ 산경투데이. 무단전재-재배포 금지]

출처 : 산경투데이(https://www.sankyungtoday.com)

 

 

Dongkuk Pharma′s Nizatidine Drug Recalled Over Safety Concerns (sankyungtoday.com)

Dongkuk Pharma′s Nizatidine Drug Recalled Over Safety Concerns