Contents
The Main Pharmaceutical Inspectorate ordered the withdrawal of a series of two asthma medications from pharmacies throughout Poland. They are Bufomix Easyhaler and Formoterol Easyhaler. The decision is immediately enforceable. Which specific servos were withdrawn from sale and why? Read and see if you have them in your medicine cabinet.
What series of asthma medications have been discontinued?
The decision to withdraw a series of drugs was issued by GIF on March 3. It concerns products in the form of inhalation powders used in patients with asthma or chronic obstructive pulmonary disease (COPD). It is about: Bufomix Easyhaler and Formoterol Easyhaler.
What specific series were withdrawn from sale?
Bufomix Easyhaler (320 mcg + 9 mcg / inh dose)
- Lot Number: 2032584; expiration date: 2022-10-31
Formoterol Easyhaler (12 mcg / measured dose):
- Series Number 2006402; expiration date: 2022-05-31
- Series Number 2035257; expiration date: 2022-11-30
The responsible entity is Orion Corporation in Finland.
Why will the Bufomix Easyhaler and Formoterol Easyhaler series disappear from pharmacies? Justification
The reason GIF decided to withdraw them from the market was the Rapid Alert that the inspectorate received from the Finnish Medicines Agency Fimea. It concerned the preventive recall of the above-mentioned series of products. As it was justified, they may be burdened with a qualitative defect of the inhaler collecting chamber, which contains the inhalation powder.
As emphasized by the inspectorate in the issued decision, it cannot be ruled out that the defect of the immediate packaging may affect the quality of medicinal products. Hence the decision to withdraw the indicated series of drugs from sale in Poland.
The Main Pharmaceutical Inspectorate reminds that a medicinal product withdrawn from the market by the decision of the GIF may not be traded. In addition, in the computer systems of pharmacies, the suspended / withdrawn medicinal product is blocked by a special IT program under the National Healthcare System (OSOZ), which prevents the sale of such a medicinal product.
All decisions on withdrawing medicinal products from the market are published on the website of the Main Pharmaceutical Inspectorate in the “Decisions and notices” tab.
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Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home. Now you can use e-consultation also free of charge under the National Health Fund.