The prescription drug must be withdrawn from sale because glass ampoules crumble when opened. The decision of the Chief Pharmaceutical Inspector is subject to immediate execution.
This is tranexamic acid, a prescription-only drug containing tranexamic acid. It belongs to a group of medicines called antihemorrhagic and antifibrinolytic drugs. It is used intravenously to prevent and treat bleeding caused by a process that inhibits blood clotting (fibrinolysis). A pharmaceutical wholesaler from Łódź and the Voivodship Pharmaceutical Inspectorates in Olsztyn and Poznań have warned that glass ampoules of the drug crumble upon opening. The destruction of the ampoules means that glass fragments can get into the medicine.
Recalled drug in ampoules - details
The Chief Pharmaceutical Inspector, in his communiqué, gave details of the seized batch of the drug.
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Tranexamic Acid for BP Injection, (Acidum tranexamicum),
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500 mg/5 ml solution for injection,
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pack of 10 ampoules,
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series number: I-11186,
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expiration date May 31, 2026,
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person in charge: Jackson Loboratories Pvt. Ltd, India,
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person who has received the consent of the Minister of Health for a temporary marketing authorization of a medicinal product: Urtica sp.z oo
The decision to recall the drug, as emphasized in the communiqué, is subject to immediate execution.
Drug recalled – risk of glass injection to patient
“Based on the data collected, taking into account the route of administration of the drug, it has been established that there may be a threat to the health and life of the patient due to the impossibility of using the drug in question during bleeding and the risk of introducing a glass-containing drug to the patient,” we read in the rationale for the decision of the GIF.
As it was added, “The main tasks of the Chief Pharmaceutical Inspector include ensuring the quality of drugs and their circulation so that patients receive the appropriate and useful drug. Medicinal products that do not meet quality requirements will be left in the warehouse.” market, and such a defect occurs in the case of a defect in glass ampoules.
Source: Wprost
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