Tiga dari 46 produk mengandung metformin yang beredar di Singapura ditemukan mengandung pengotor nitrosamin, N-nitrosodimetilamin (NDMA), di atas batas yang diterima secara internasional. HSA pun meminta produsen melakukan penarikan tiga produk tersebut.
Informasi rinci dapat dibaca dari situs HSA: https://www.hsa.gov.sg/announcements/news/hsa-recalls-three-out-of-46-metformin-medicines
Pernyataan Direktur CDER FDA Janet Woodcock:
ReplyDeletehttps://www.fda.gov/news-events/press-announcements/statement-janet-woodcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found
Respon Health Canada:
ReplyDeletehttps://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71831a-eng.php
Surat pernyataan Drug Office Hong Kong:
ReplyDeletehttps://www.drugoffice.gov.hk/eps/upload/eps_news/38927/EN/1/Some%20metformin%20medicines%20found%20to%20contain%20N-nitrosodimethylamine(NDMA).pdf
Pernyataan EMA:
ReplyDeletehttps://www.ema.europa.eu/en/news/ema-update-metformin-diabetes-medicines
Pernyataan MHRA UK:
ReplyDeletehttps://www.gov.uk/government/news/metformin-diabetes-medicines-mhra-update
MFDS Korsel:
ReplyDeletehttps://www.mfds.go.kr/brd/m_99/down.do?brd_id=ntc0021&seq=43866&data_tp=A&file_seq=2