Gastrografin
GIF decision: Withdrawal from market
What does this decision mean?
- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
Based on tests of a representative number of batches of the medicinal product manufactured from December 2020 to April 2024, the presence of N-nitroso-meglumine contamination was confirmed, with a content exceeding the acceptable intake (AI) limit of 100 ng/day. N-nitroso-meglumine is considered a potential carcinogenic impurity. Potential effects: increased carcinogenic risk and harm to patient health.
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