Tullex
GIF decision: Withdrawal from market, Marketing prohibition
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- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
- • Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.
Out-of-specification result in long-term stability testing: during the sterility test microbial growth was observed in a batch of the product, indicating potential microbiological contamination of the solution for injection. Potencjalne skutki: infection after administration of the drug, including severe systemic infections.
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