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Allergovit – product series withdrawn from the market. GIF warning

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One series of the medicinal product Allergovit has been withdrawn from the market – informed the Main Pharmaceutical Inspectorate (GIF). The reason was mislabeling of the vials. The product can be returned to pharmacies.

It is about the medicinal product Allergovit (Plant pollen allergoids 006 – grass 60%, 158 – rye 40%); doses for initial treatment: concentration A – 1000 TU/ml, concentration B – 10,000 TU/ml) with lot number G1001660-06 and expiration date 07.2023.

The responsible entity is Allergopharma GmbH & Co. KG, Hermann-Koerner-Str. 52 D-21465 Reinbek, Germany.

Allergovit product series withdrawn from the market

The justification for the withdrawal decision indicated that the Main Pharmaceutical Inspectorate received a notification from Przedsińôbiorstwo Nexter Sp. z o. o. with its registered office in Przyszowice, operating a pharmaceutical wholesale store, regarding incorrect labeling of a specific series of Allergovit medicinal product – both vials in the package were marked with the same color of the cap.

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Vials containing the A1000 TU/mL concentration label have been labeled with the same solid dark blue cap and vials containing the B-10000 TU/mL concentration label have the same solid dark blue flip cap.

The GIF pointed out that there is a risk of misleading the medical staff, and thus taking too high a dose of the drug by the patient, which may result in a threat to the life and health of patients.

In the announcement, the Chief Pharmaceutical Inspector informed about the possibility of returning a specific series of the product to pharmacies.

Read more: From January in the EU “all herbs are banned”? Not true

Main photo source: Shutterstock



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