The decision is related to the finding of a quality defect.
GIF is recalling two series of one of the most popular cold remedies from pharmacies
Published Jan. 3, 2022 09:37
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It is about Polopyrin Hot Max, a drug used in the case of fever, cold and flu symptoms such as: headache, sore throat, muscle and joint pain.
The Main Pharmaceutical Inspector decided to withdraw the medicinal product from the market nationwide:
Polopiryna Max Hot (Acidum acetylsalicylicum + Acidum ascorbicum + Coffeinum), (500 mg + 300 mg + 50 mg)/sachet, powder for oral solution, 8 sachets batch number: 902038 expiry date: 04.2022 batch number: 902272 date validity: 06.2022.
The entity responsible is Zakłady Farmaceutyczne POLPHARMA S.A. with headquarters in Starogard Gdański.
The Main Pharmaceutical Inspectorate received an application from the MAH to withdraw the above-mentioned series of the medicinal product Polopiryna Max Hot. The reason for the decision to withdraw is confirmation of the increased content of salicylic acid in the stability studies. The decision was made immediately enforceable.
Source: GIF
