Important antiviral drug withdrawn from pharmacies. The decision is immediately enforceable

Important antiviral drug withdrawn from pharmacies.  The decision is immediately enforceable

A series of antiviral drugs used, among others, for herpes infections, have been withdrawn from the market. The Chief Pharmaceutical Inspector issued a communiqué on this matter.

This is Aciclovir Jelfa, which is used, among others, in the treatment of infections caused by the herpes virus, but also by the chicken measles and shingles viruses.

Aciclovir Jelfa – details of the withdrawn drug

The Chief Pharmaceutical Inspector provided details of the withdrawn batch of the drug:

  • Aciclovir Jelfa (Aciclovirum), powder for solution for infusion,

  • 250mg, packaging: 5 vials of powder,

  • GTIN number: 05909990405213,

  • series number: 111121,

  • expiry date: 30/11/2024,

  • responsible entity: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland.

The reason for the withdrawal is a quality defect of the product, which was found during tests of samples of the medicinal preparation by the National Institute of Medicines. It turned out that the preparation contained particles of unknown origin visible to the naked eye. As stated in the announcement, a threat to the patient’s health or life cannot be ruled out for this reason.

Why are medicines withdrawn from pharmacies?

As GIF reminds in its announcement, the Pharmaceutical Inspection authorities issue decisions to suspend, prohibit the introduction, withdrawal from the market or use of medicinal products in the event of suspicion or finding that a given product does not meet the established quality requirements or has been falsified. “The basic tasks of the Chief Pharmaceutical Inspector include ensuring the quality of medicinal products and their circulation, so that patients receive the right and high-value medicinal product. The basic task of the Pharmaceutical Inspection authorities is primarily preventive action, i.e. preventing the possibility of medicinal products that do not meet quality requirements being left on the market,” we read in the decision.

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