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GIF: Series of anticoagulant drug withdrawn from market

MedExpress Team

Medexpress

Published Nov. 20, 2025 11:06

The Chief Pharmaceutical Inspector has recalled a batch of an anticoagulant drug from circulation nationwide.
GIF: Series of anticoagulant drug withdrawn from market - Header image
Źródło: GIF

The Chief Pharmaceutical Inspector has issued a decision, No. 41/WC/2025, to withdraw from the market the medicinal product: POLIPARIN 25000 IU/5 ml (heparin sodium, solution for injection and infusion) in a package of 5 ml x 1 vial. The recall concerns batch E38310003A with an expiration date of August 31, 2026.

The responsible entity is Polifarma Ilaç San. ve Tic. A.Ş., and the entity that has obtained approval for the drug's temporary marketing authorization is Zakłady Farmaceutyczne Polpharma S.A.

Disturbing reports from the hospital

The first indications of problems came to Polpharma on September 15, 2025, through a pharmaceutical wholesaler, which was informed by one of the hospitals. The report concerned cases of "gangrenous coagulation after use of the product in several patients." As reported, not all individuals were affected, and the situations did not lead to life-threatening situations, but were an important safety signal.

After analyzing the information, Polpharma recommended halting marketing of the series. On September 17, 2025, the GIF issued a decision to temporarily suspend it nationwide.

The decision was given the order of immediate enforceability.

What is Poliparin used for?

Poliparin is an anticoagulant containing heparin sodium. It is used in, among other things:

  • Prevention and treatment of deep vein thrombosis,
  • Treatment of pulmonary embolism,
  • Prevention of perioperative thrombosis,
  • acute coronary syndromes,
  • During hemodialysis.

Source: GIF

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