Spanish medicines regulator withdraws laxative after detecting contents above permitted level

The Spanish agency for medicines and health products (Aemps) has ordered the withdrawal of a laxative after an analysis detected that an unwanted substance exceeded maximum limits.

As Aemps said in a statement, the detected "impurity" does not pose a life-threatening risk to the patient. Nevertheless, the defect is of 'medium risk' and requires the withdrawal of the product.

The alert concerns about 20 batches of Emuliquen Laxante: the batches, in 230 millilitre bottles, are 1129, 1130, 1131, 1132, 1133, 1134, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148 and 1149, with expiration dates 30 April 2027, 30 June 2027 and 31 July 2027.

In addition, Aemps has withdrawn packs of ten sachets (lots 1135, 1136 and 1137) and packs of 200 sachets (lot 1135). All of them expire on 30 November 2026.

Laboratorio Lainco SA manufactures Emuliquen Laxante. It relieves occasional constipation in adults. It contains liquid paraffin and sodium picosulfate as active ingredients and belongs to the group of medicines called stool softeners.