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- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
Tests showed the presence of N-nitroso-meglumine contamination exceeding the acceptable daily intake and the temporary LTL limit for contrast agents. N-nitroso-meglumine is regarded as a potentially carcinogenic impurity. Potential effects: increased risk of carcinogenic effects and other complications related to long-term exposure.
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