The Chief Pharmaceutical Inspectorate announced the decision to immediately retreat 1 of the popular Acap Extra series from pharmacies across Poland. The reason is the mechanical contamination detected in the production process. The Communication stresses that the decision is preventive and that all patients should check their home first-aid kits immediately.
Acap Extra withdrawn from the market. For a circumstantial series
On May 17, 2025, the Chief Pharmaceutical Inspectorate issued a decision to retreat Apap Extra (Paracetamol + Caffeine), pack of 10 tablets, U1508501 series, expiry date: 10.2027. The decision applies throughout Poland.
The direct origin of withdrawal was suspected contamination of 1 of the batches by a abroad body. Manufacturer, company US PHARMACIA Sp. z o.o., reported a problem after the crash was detected – damage to the granulator discharge valve seal during production. The investigation has shown that the problem concerns only 1 series, but the GIF has decided to immediately retreat this batch from the marketplace due to potential risks to public health.
Why does it matter? hazard to patients
Apap Extra is one of the most commonly utilized painkillers in Poland. Contains paracetamol and caffeine - active substances utilized to treat headaches, muscles, fever or migraines. The product is available without a prescription, which makes it available in many home first-aid kits.
Mechanical pollution, even a single component from a manufacturing machine, can be dangerous to wellness if you swallow a contaminated tablet. Therefore, the Chief Pharmaceutical Inspectorate decided to retreat the series and called on patients to Discontinuation of usage if they have a pack marked U1508501.
What should I do with the withdrawal?
GIF recalls that Misuse of retention and usage of medicines may lead to serious wellness complications, in peculiar in the case of products not complying with quality standards. If you have a withdrawn Apap Extra series:
- Do not take this medicine, even if the packaging looks intact,
- return the pack to the nearest pharmacywhich is obliged to adopt and dispose of the product,
- Stay alert to another medicines, check the series numbers and expiration dates.
Poland at the forefront of drug consumption without a prescription
Data show that Over 90% of Poles take medicines at least erstwhile a year and all 3rd – all day. The average yearly intake of medicines available without a prescription is 7 to 8 packs per person, which ranks Poland in a close European lead.
The most commonly utilized medicines are painkillers, including ibuprofen. While their availability in pharmacies, drugstores and supermarkets may seem an advantage, experts inform against disregarding the hazard of adverse reactions and pharmacological interactions.
Potential effects of drug abuse:
- liver and kidney damage,
- addiction,
- masking symptoms of serious diseases,
- dangerous interactions with another medicines,
- OD complications.
The function of the GIF in public health
Chief Pharmaceutical Inspectorate is liable for the supervision of the quality, safety and legality of medicinal products in Poland. His competence includes:
- control of production facilities (compliance with Good Manufacturing Practice),
- analysis of samples of drugs from the marketplace (pharmaceuticals, wholesale),
- publication of notices on the suspension or withdrawal of products.
GIF besides cooperates with the Committee for Medicinal Products Registration Office and the National Medicines Control Institute, monitoring adverse reactions reported by doctors and patients.
The withdrawal of the Apap Extra series is further evidence that the strategy of drug supervision in Poland works effectively and responds to distress signals. Regular checks and fast consequence to irregularities defend patients' wellness and increase assurance in public institutions.
A Future Perspective
Although withdrawal of 1 batch does not mean an overall hazard to all patients, this situation is an crucial reminder of the request for informed usage of medicines and regular verification of information on products available on the market. Poles should make a habit of checking GIF messages, as well as reading leaflets and markings on packaging.
In the coming weeks, the GIF may carry out additional checks to guarantee that akin cases do not happen in another series or in another producers. Patients should be alert and follow the recommendations of the Pharmaceutical Surveillance Authority.
Continued here:
GIF withdraws popular drug from pharmacies. Check if you have it at home – urgent message
