Loperamid APTEO MED recalled in Poland due to quality defects

Loperamid APTEO MED drug recall diarrhea medication pharmaceutical quality defect active substance deficiency

The Chief Pharmaceutical Inspectorate (GIF) has issued an immediate recall of nine batches of the anti-diarrheal medication Loperamid APTEO MED in Poland. The recall affects both 20-capsule and 10-capsule packs containing 2 mg of loperamide.

The decision follows findings by the National Institute of Drugs, which identified a quality defect regarding the content of the active substance. Testing revealed that certain batches contained levels below the required specification, posing a risk that the medication may not work with the intended efficacy. The manufacturer, Synoptis Pharma Sp. z o. o., attributed the issue to systemic instability and insufficient reproducibility in the production process.

The affected batches include:

20-capsule packs (GTIN: 05909991453596): IJW024002, IJW024003, IJW024006, IJW024009, IJW0225003, IJW0225004, and IJW0225006.

10-capsule packs (GTIN: 05909991444914): IJW014010 and IJW0125007.