Blood pressure medicine contaminated and withdrawn from pharmacies. GIF warns
The Chief Pharmaceutical Inspectorate issued a notice withdrawing from the market and banning the introduction to the market of a drug used to treat patients with hypertension and heart failure. The preparation does not meet quality requirements.
The decision of the Chief Pharmaceutical Inspector concerns a drug called Symibace. These are coated tablets containing the active substance Cilazaprolum. They are used to treat patients diagnosed with hypertension or heart failure (a condition in which the heart does not pump sufficient amounts of blood necessary for the proper functioning of the body).
Symibace – details of the withdrawn drug
In a published statement, the Chief Pharmaceutical Inspectorate provided details of the withdrawn batch of the drug:
Symibace (Cilazaprolum), 2.5 mg, film-coated tablets, 28 tablets
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GTIN: 05909990734573,
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batch number: 28C012A,
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expiry date: 31/07/2025
Symibace (Cilazaprolum), 5 mg, film-coated tablets, 28 tablets
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GTIN: 05909990734580,
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series number: 14S012A,
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expiry date: 31/07/2025
The entity responsible for the production of the mentioned medicinal products is Symphar sp. z o. o. based in Warsaw. Additionally, the Chief Pharmaceutical Inspectorate banned the marketing of the above-mentioned drugs in the series mentioned above throughout the country. The decisions were made immediately enforceable.
Why was the antihypertensive drug withdrawn from the market?
A quality defect was detected in the indicated antihypertensive drugs. The tests carried out showed that the medicinal products were contaminated. The cause of these irregularities could not be identified. However, it is known that taking a defective preparation may pose a threat to life and health. “For the above reasons, the Chief Pharmaceutical Inspector decided that in order to protect (…) patients who could take a medicinal product that did not meet the quality requirements, it was justified and necessary to make this decision immediately enforceable,” we read in the GIF press release.
