The Chief Pharmaceutical Inspectorate decided to suspend 49 batches of the medicinal product called Enema. The reason is the finding of discrepancies in appearance “in the form of turbidity of the solution”. The GIF made the decision immediately enforceable.
The Chief Pharmaceutical Inspectorate announced the suspension throughout the country of trade in a medicinal product called:
Enema (Dinatrii phosphas dodecahydricus + Natrii dihydrogenophosphas monohydricus), (32.2 mg + 139 mg)/ml, rectal solution, 1 bottle of 150 ml – GTIN 5909990298716, for the following series:
batch number: 05424, expiry date: 04/2026, batch number: 05524, expiry date: 04/2026, batch number: 05624, expiry date: 04/2026, batch number: 05724, expiry date: 04/2026, batch number: 05824, expiry date: 04/2026, batch number: 06424, expiry date: 04/2026, batch number: 06524, expiry date: 04/2026, batch number: 06624, expiry date: 04/2026, batch number: 06724, expiry date: 04/2026, batch number: 06824, expiry date: 05/2026, batch number: 06924, expiry date: 05/2026, batch number: 07024, expiry date: 05/2026, batch number: 07124, expiry date: 05/2026, batch number: 08824, expiry date: 07/2026, batch number: 08924, expiry date: 07/2026, batch number: 09024, expiry date: 07/2026, batch number: 09124, expiry date: 07/2026, batch number: 09224, expiry date: 07/2026, batch number: 09324, expiry date: 07/2026, batch number: 09424, expiry date: 07/2026, batch number: 09524, expiry date: 08/2026, batch number: 09624, expiry date: 08/2026, batch number: 09724, expiry date: 08/2026, batch number: 09824, expiry date: 08/2026
and Enema (Dinatrii phosphas dodecahydricus + Natrii dihydrogenophosphas monohydricus), (32.2 mg + 139 mg)/ml, rectal solution, 50 bottles of 150 ml – GTIN 5909990298723, for the following series:
batch number: 05924, expiry date: 04/2026, batch number: 06024, expiry date: 04/2026, batch number: 06124, expiry date: 04/2026, batch number: 06224, expiry date: 04/2026, batch number: 06324, expiry date: 04/2026, batch number: 07224, expiry date: 05/2026, batch number: 07324, expiry date: 05/2026, batch number: 07424, expiry date: 06/2026, batch number: 07524, expiry date: 06/2026, batch number: 07624, expiry date: 07/2026, batch number: 07724, expiry date: 07/2026, batch number: 07824, expiry date: 07/2026, batch number: 07924, expiry date: 07/2026, batch number: 08024, expiry date: 07/2026, batch number: 08124, expiry date: 07/2026, batch number: 08424, expiry date: 07/2026, batch number: 08524, expiry date: 07/2026, batch number: 08624, expiry date: 07/2026, batch number: 09924, expiry date: 09/2026, batch number: 10024, expiry date: 09/2026, batch number: 10124, expiry date: 09/2026, batch number: 10224, expiry date: 09/2026, batch number: 10324, expiry date: 09/2026, batch number: 10424, expiry date: 09/2026, batch number: 10524, expiry date: 10/2026.
The responsible entity is Laboratorium Galenowe Olsztyn Sp. z o. o
Reason for withdrawal
According to GIF, the office received an application from the responsible entity with a recommendation to suspend the above-mentioned product from trade in Poland. Enema product series.
“The responsible entity found a discrepancy in appearance in the form of turbidity of the solution in the above-mentioned product batches. Due to the fact that the primary cause has not been determined, the responsible entity recommended suspending the marketing of the product batches indicated in the decision, until the cause of the identified non-compliance is clarified” – we read in the justification of the decision,
Enema is used, among others, for cleansing the large intestine before diagnostic tests and before and after surgery or childbirth, as well as for constipation.
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