Popular Painkiller Urgently Withdrawn from Market. Check if You Have It in Your Medicine Cabinet

The announcement issued by the Chief Pharmaceutical Inspector concerns a drug called Apap Extra. The drug is used to relieve acute pain and treat colds and flu. It has antipyretic and anti-inflammatory effects. The GIF decision concerns some batches of the indicated drug. Check why they were withdrawn from circulation and review your medicine cabinet.

Apap withdrawn from pharmacies - details of the decision GIF

The decision of the Chief Pharmaceutical Inspector is related to irregularities that occurred in the drug production process. It concerns only some batches of the drug. Below we provide all the necessary information regarding the defective medicinal product:

Apap Extra (Paracetamolum + Coffeinum) 500 mg + 65 mg

• form: coated tablets, 10 tablets in blister,
• GTIN 05909991107123,
• series number: U1508501,
• expiry date 10.2027,
• Responsible entity: "US PHARMACIA" LIMITED LIABILITY COMPANY with its registered office in Wrocław

The Chief Pharmaceutical Inspector decided not only to withdraw the defective batches of the drug from sale. He also banned their introduction to the Polish market. Both decisions were given immediate enforceability.

Why was Apap withdrawn from sale?

During the production of the Apap drug, contamination of the agent with a foreign body occurred. It occurred at the stage of unloading the granulate, due to damage to the seal of the granulator discharge valve. In connection with this, the pharmaceutical manufacturer recommended withdrawing the defective series from pharmacies.

The identified non-compliance in the form of a foreign body in the tablet may affect the safety of use of the medicinal product in question. Therefore, a risk to human health and life resulting from leaving the batch of the medicinal product in circulation cannot be ruled out - we read in a statement made available by the Chief Pharmaceutical Inspector.

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