Tracing the origin of counterfeit drug NEXIUM 40mg containing only 17.2% of the content

On May 23, the Drug Administration of Vietnam ( Ministry of Health ) sent a document to the Department of Health of provinces and cities regarding the inspection, handling, and tracing of the origin of the fake drug NEXIUM 40mg containing only 17.2% of the content compared to the label.

Specifically, in the document, the Drug Administration of Vietnam said it had received an official dispatch with an analysis report from the Hanoi Center for Drug, Cosmetic and Food Testing, reporting that the product sample had information on the label as NEXIUM 40mg Enterik Kapli Pellet Tablet (Esomeprazole), batch number: 23H420, expiry date: 9-2027, with no information on the circulation registration number and/or import license, manufacturing facility, and importing facility on the label.

Drug samples were taken at Duc Anh Pharmacy, under Duc Anh Pharmaceutical and Medical Equipment Company Limited, No. 8 Huynh Thuc Khang extended (Dong Da, Hanoi).

The drug sample did not meet the quality requirements for the quantitative index of Esomeprazole according to the reference document, Nexium Tablet Base Standard, registration number: VN-19782-16 of the manufacturer AstraZeneca, with the result of 6.91mg/tablet (17.27% of the content stated on the label).

The Drug Administration of Vietnam requests the Hanoi Department of Health to urgently report to the Steering Committee 389 and coordinate with the police, market management agencies, the local Steering Committee 389 and relevant authorities to conduct an inspection of the above-mentioned Duc Anh Pharmacy, to trace the origin of the product batch with the information on the label being NEXIUM 40mg Enterik Kapli Pellet Tablet (Esomeprazole), on the label there is no information about the registration number and/or import license, manufacturing facility, and importing facility.

The Ministry of Health requested the Hanoi Department of Health to strictly handle violating facilities according to regulations, and report the results of inspection, examination, and handling to the Department of Drug Administration before May 27.

The Drug Administration of Vietnam also requested the Department of Health of provinces and cities to communicate and inform drug trading and using establishments and people not to buy/sell or use the above-mentioned fake NEXIUM® 40mg Enterik Kapli Pellet Tablet (Esomeprazole); only buy and sell drugs at legal drug trading establishments; do not buy/sell drugs of unknown origin; promptly report any suspicious signs of production and trading of fake drugs or drugs of unknown origin to health agencies and relevant competent agencies.

NEXIUM 40mg is a proton pump inhibitor that reduces the amount of acid produced in the stomach, used to treat the symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid./.

(Vietnam+)

Source: https://www.vietnamplus.vn/truy-tim-nguon-goc-thuoc-gia-nexium-40mg-chi-chua-172-ham-luong-post1040343.vnp