The issue is APAP for children FORTE. What was the reason for the decision of the Chief Pharmaceutical Inspector?
Popular painkiller and antipyretic for children disappears from pharmacies. Check the batch numbers
Published May 29, 2023 08:51
Fot . Robert Robaszewski / Agencja Gazeta
The Chief Pharmaceutical Inspector has decided to suspend the following medicinal product from marketing throughout the country: APAP for children FORTE, Paracetamolum, oral suspension, 40 mg/ml, 150 ml bottle:
1. series J1546, expiration date: 12.2024
2. series J1547, expiration date: 12.2024
3. series J1548, expiration date: 12.2024
4. series J1549, expiration date: 12.2024
5. series L0968, expiration date: 06.2025
6. series L0969, expiration date: 06.2025
7. series L0970, expiration date: 06.2025
8. series L0971, expiration date: 06.2025
9. series L1151, expiration date: 07.2025
10. series L1152, expiration date: 07.2025
11. series L1153, expiration date: 07.2025
12. series L1154, expiration date: 07.2025
13. series L1813, expiration date: 11.2025
14. series L1814, expiration date: 11.2025
15. series L1833, expiration date: 11.2025
16. series L1834, expiration date: 11.2025
The responsible entity is US Pharmacia Sp. z o.o., based in Wroclaw, Poland.
The decision was given the order of immediate enforceability.
The Main Pharmaceutical Inspectorate has received reports from the Regional Pharmaceutical Inspectorates in Bydgoszcz, Gorzow Wielkopolski, Krakow and Gdansk about numerous reports from pharmacies open to the public about the improper appearance of the drug in comparison with the drug product characteristics. The suspension in the bottle contained gas bubbles, due to foaming it had an increased volume filling the entire package. In several cases, the suspension was heterogeneous and stratified. The responsible entity, as a result of signals received from pharmacies and pharmaceutical wholesalers about the suspicion of the occurrence of a quality defect in the medicinal product Apap for children Forte, oral suspension 40 mg/ml, op. 150 ml., made its own decision to suspend the above-mentioned series of the drug in question from the market until the completion of explanatory actions. Due to a reasonable suspicion of a quality defect, referred to above, the Chief Pharmaceutical Inspector has made a decision to suspend the marketing throughout the country of the above-mentioned series of the medicinal product in question.
Source: GIF
