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The Main Pharmaceutical Inspectorate ordered the withdrawal of several series of the drug for constipation from pharmacies throughout Poland. It’s about Lactulose-MIP syrup. The decision is immediately enforceable. What specific series were withdrawn from sale and why? Read and see if you have them in your medicine cabinet.
- GIF decided to suspend the sale of selected series of Lactulose-MIP constipation syrup, 9,75 g / 15 ml
- The reason for the withdrawal is a quality defect (notification of the threat of microbiological contamination of the active substance of the drug)
- Check the current list of recalled drugs
- More information can be found on the Onet homepage
Lots of Lactulose-MIP laxative syrup discontinued
The decision (No. 13) to withdraw the Lactulose-MIP GIF syrup series was issued on June 13. As we read in the first announcement, on June 8, 2022, the Main Pharmaceutical Inspectorate received information about the legitimacy of withdrawing the medicinal product Lactulose-MIP, 9,75 g / 15 ml syrup with the following batch numbers and expiry dates:
batch number: 2900301 expiry date: 09
batch number: 2900401 expiry date: 09
batch number: 2900601 expiry date: 09
batch number: 2901501 expiry date: 09
batch number: 2901601 expiry date: 11
batch number: 2901701 expiry date: 11
batch number: 2901801 expiry date: 11.2024
The application of the MAH (MIP Pharma Polska Sp. Z oo) to the Main Pharmaceutical Inspector in the above case was the result of the notification by the manufacturer of the active substance of an unexpected result beyond the specification in microbiological tests. According to GIS, on June 9 a Rapid Alert from Germany was received recommending the withdrawal of the above-mentioned series intended for the Polish market, in connection with the already mentioned risk of microbiological contamination of the active substance of the product.
The rest of the text is below the video.
Another Rapid Alert on a drug for constipation, another GIS decision
On June 9, 2022, GIS received a Rapid Alert from Germany recommending that another series of Lactulose-MIP syrup, 9,75 g / 15 ml, be withdrawn from the market. On its basis, GIS decided to suspend the sale of the product with the batch number: 3139208, expiry date: 09 (decision no.2024). The reason is also the risk of microbial contamination of the active substance used to manufacture the product.
The responsible entity in the exporting country is MIP Pharma Austria GmbH (parallel importer: InPharm Sp. Z oo).
As GIS reminds us, the occurrence of a quality defect in a medicinal product, as we are dealing with in the above cases, “does not require evidence for the possibility of an immediate threat to health or life, because it is enough to justify the potential risk. In this sense, pharmaceutical inspection has the task of reacting when it is potentially threatened ”.
When you struggle with chronic constipation, it is worth undergoing diagnostic diagnostic tests for bowel diseases.
We encourage you to listen to the latest episode of the RESET podcast. This time we devote it to self-compassion – a trend that has developed very strongly in the United States, but is still in its infancy in Poland. What is it and how does it affect our daily functioning? You will hear about this and many other issues related to self-compassion in the latest episode of our podcast.