The Spanish Medicines Agency of a class 3 defect in the medicine and asks that the affected batches not be consumed.
The Spanish Agency for Medicines and Health Products (Aemps), dependent on the Ministry of Health, has ordered the withdrawal and return to the laboratory through the usual channels of several batches of the drug Nico-hepatocyn, a drug used to treat occasional constipation. Specifically, the affected products are those corresponding to the numbers M004 and M006, expiring on April 30, 2021; and M010, M011 and M012, of October 31, 2021.
In a notification issued this Monday, Aemps informs that this drug is presented in containers of 60 coated tablets and belongs to the company Uriach Consumer Healthcare SL, with headquarters in Barcelona, being the manufacturing laboratory J. Uriach y Compañía SA.
After the analyzes carried out, the Aemps has detected “out of specification results in stability studies of the Aloe del Cabo titration test”. The Agency has classified the defect as class 3. The quality defects of the drugs are classified by the Aemps in three classes (1, 2 and 3), class 1 being the one that corresponds to a possible higher risk and class 3 the one with a lower risk.
Nico-hepatocyn is a medicine used for the short-term treatment of occasional constipation in adults. Facua, the organization that watches over the rights of consumers, recommends that users who have the affected medicine in their homes to refrain from consuming it and in the event that they have to continue with their treatment, return it to the pharmacy where it have been purchased to exchange it for another unaffected container.
For its part, the Aemps urges all the autonomous communities to monitor the withdrawal of the affected batches of the drug Nico-hepatocyn tablets.