Sales of a drug for irritable bowel syndrome suspended. Urgent decision GIF
A batch of a drug used to treat the symptoms of irritable bowel syndrome has a serious quality defect – informed the Chief Pharmaceutical Inspector (GIF). Therefore, trading in the batch of the drug has been suspended and the decision is immediately enforceable.
This is a series of Auroverin MR which is used to treat the symptoms of irritable bowel syndrome (spasms and pain in the intestines). The medicine is available on prescription. Now it turned out that in one of the batches of the drug the active substance was not released as it should. GIF received a report from a study conducted by the National Medicines Institute – the study showed that the product did not meet the quality requirements due to a negative test result regarding the release parameter of mebeverine hydrochloride (the active substance of the drug).
Auroverin MR – details of the suspended series
In its announcement, GIF provided details of the suspended product series:
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Auroverin MR (Mebeverini hydrochloridum), modified-release capsules, hard, 200 mg, pack of 60 capsules,
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GTIN 05909991340919,
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batch number: EMBCD2064A,
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validity date: 07/2025,
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responsible entity: Aurovitas Pharma Polska sp. z o. o. based in Warsaw.
The GIF’s decision is immediately enforceable.
Auroverin MR – what is the quality defect of the drug batch?
The result of the study conducted by the National Medicines Institute showed irregularities in the release parameter of mebeverine hydrochloride. These parameters were below the lower acceptability level specified in the product specification requirements. “This means that the release of the active substance of the medicinal product (mebeverine hydrochloride) was slower than permitted by the quality requirements established for the product, which obviously affects the effectiveness of this product. It should be emphasized that the acceptance criteria for the quality specification parameters indicated in the registration documentation medicinal product are determined based on extensive research on the safety of use of this product. Therefore, any exceedance must be considered a circumstance constituting a real and direct threat to the health or life of patients – until the reason for the deviation is clearly identified and it is proven that it is not it constitutes such a threat,” the GIF statement said.
