“Cetal”- Recall of certain batches due to mistake in the Arabic leaflets regarding dose calculation:

The Drug Factories Inspection Department at the Central Administration of Pharmaceutical Affairs (CAPA) has decided to recall all batches produced during years 2015-2016 of all dosage forms of the pharmaceutical product “Cetal”, manufactured by EPICO; because of typing mistake in some Arabic insert leaflets regarding the calculation of “Cetal drops/suspension” dose in infants & children.

This decision was circulated to the Manufacturers, Marketing Authorization Holders (MAH) and Distributers to discontinue distribution of stocks of and recall the amount sold of these batches from pharmacies.

This decision was taken based on a pharmacovigilance committee recommendation, because although no “overdose” case reports were reported up till now; however this mistake in dose calculation (in the Arabic translation only) may result in overdose.

If you are taking Cetal drops/Suspension, please adhere to the dose stated in the English leaflet.

It is important to mention that there is no risk for patients who used this product with correct doses according to physician/pharmacist instructions, with the emphasis to return the quantities pharmacies in accordance with the instructions in the publication.

CETAL (Paracetamol /acetaminophen) is a pain reliever and a fever reducer. It is available in Tablets- Drops - Suspension - Suppositories.