Hypertension drug with suspected qualitative defect. Check the lot number

The Main Pharmaceutical Inspector decided to suspend the national market of the medicinal product: Sumilar HCT (Ramiprilum + Amlodipinum + Hydrochlorothiazidum), 5 mg + 5 mg + 12.5 mg, hard capsules batch number: 12574261 expiry date: 04.2023 .

The responsible party is Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria 2).

The Main Pharmaceutical Inspectorate received information from the Provincial Pharmaceutical Inspectorate in Kielce about the receipt of a suspected quality defect notification from the pharmacy for Sumilar HCT medicinal product, serial number 12574261, due to the identification of capsules with an incorrect color appearance inside the blister. Due to the suspicion of a quality defect, the Main Pharmaceutical Inspector decided to suspend the above-mentioned batch of the medicinal product in question until obtaining explanations from the MAH.

Source: GIF