Chief Pharmaceutical Inspectorate withdraws Loperamid APTEO MED nationwide due to quality defect affecting effectiveness.
Immediate Nationwide Withdrawal
The Chief Pharmaceutical Inspectorate (GIF) has decided to immediately withdraw the popular medicinal product Loperamid APTEO MED 2 mg from the market. This is the result of a detected quality defect that could have affected the effectiveness of the medication. The GIF decision is immediate and applies nationwide.
Product Details
The recall affects specifically the Loperamid APTEO MED product with the following parameters:
Name: Loperamid APTEO MED
Active Substance: loperamidi hydrochloridum
Strength: 2 mg
Form: hard capsules
Packaging: 20 capsules
GTIN: 05909991453596
Batch Number: IJW024001
Expiry Date: 31.12.2026
Responsible Entity: Synoptis Pharma Sp. z o.o. (Warsaw)
License Number: 26184
The withdrawal concerns only the specified batch, not the entire product in all batches.
Reason for Withdrawal
The reason for the decision were stability test results, which showed that in the 18th month of storage, the product did not meet quality standards. An insufficient content of the active substance was found compared to the lower limit specified in the specification. According to GIF, reduced content of the active substance may lead to reduced therapeutic effectiveness, which poses a potential threat to patient health.
Practical Implications of the Decision
The immediate enforcement nature of the decision means that the recalled product must be removed from pharmacy shelves immediately.
Instructions for Patients
If you have Loperamid APTEO MED at home:
The withdrawal of the medicine does not automatically mean a life-threatening situation, however, using a product with reduced content of the active substance may not bring the expected therapeutic effect.
