Some series of popular products were withdrawn from sale.
According to the portal “RMF FM”, GIF has issued an announcement regarding the withdrawal from sale of some series of medicinal products. People who have them should not accept them. What specificities are we talking about?
GIF message
On Twitter, GIF published information about the withdrawal of two medicinal products from the market in our country. The first is solution for injection 100 mg/ml Vitaminum C Teva (Acidum ascorbicum) . Batch number X05459A with expiry date until March 31, 2023 was withdrawn from sale.
The entity responsible is Teva Pharmaceuticals Polska Sp. z o.o. and it was this company that informed about the discovery of a quality defect in the product. It turned out that the results obtained during the tests were outside the accepted specification limits for the drug.
GIF wycofuje z obrotu produkt leczniczy:
Vitaminum C Teva (Acidum ascorbicum)
roztwór do wstrzykiwań 100 mg/ml
nr serii: X05459A
termin ważności: 03.2023
podmiot odpowiedzialny: Teva Pharmaceuticals Polska Sp. z o.o.https://t.co/j9IfEboKpE— Główny Inspektorat Farmaceutyczny (@GIF_GOV_PL) July 19, 2022
The exact content of the decision A GIF about this product can be found here.
Second product withdrawn from sale
The second product that has been withdrawn from pharmacies in Poland is Amiodarone Hameln, 50 mg/ml with the batch number 139503A with the expiry date until September 2023. The Marketing Authorization Holder for this medicine is Hameln Pharma GMBH.
For this product, the reason for the recall decision is a notification sent from the Rapid Alert system, which contained information about increased crystallization of the product, which is considered a quality defect.
GIF wycofuje z obrotu produkt leczniczy:
Amiodaron Hameln (Amiodaroni hydrochloridum) koncentrat do sporządzania roztworu do
wstrzykiwań lub infuzji
50 mg/ml
nr serii: 139503A
termin ważności: 09.2023
podmiot odpowiedzialny: hameln pharma gmbhhttps://t.co/EPKKxwV1Jg— Główny Inspektorat Farmaceutyczny (@GIF_GOV_PL) July 19, 2022
You can find the exact wording of the GIF decision about this product here.
You should not take any of the products mentioned in this release. Drugs withdrawn from the market, as well as those with expired shelf life, should be handed over to pharmacies. Under no circumstances should they throw them into the ordinary garbage.
Do you have any of these medicines in your home medicine chests?
