Information about the recall of the medicinal product Kerasal ointment due to the expiration of the marketing authorisation
The company Medical Intertrade d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of all batches of the medicinal product Kerasal ointment. The medicinal product is being recalled due to regulatory reasons, which means the expiration of the marketing authorisation granted by HALMED and the expiration set in the Paragraph 2 of the Art. 113 (OG, No 76/13) under which batch may be on the market no later than 18 months after the expiration or revocation of the marketing authorisation, if not expired before.
Pharmacies are advised to return the left over product stocks to wholesalers who distributed the product.
We remind marketing authorisation holders that they are obliged to notify HALMED at least two months before a temporary or permanent interruption of the supply chain by completing the Cover letter and Table with information about medicinal products concerned and sending them by e-mail to firstname.lastname@example.org.