Orion has decided to recall Burana-Caps capsules from consumers as an extra precautionary measure. The reason for the recall is the possible mix up of foreign capsules with the product. No foreign capsules have been detected in Orion's Burana-Caps.
Burana-Caps capsules are manufactured at Orion's European contract manufacturer specialised in the production of softgel capsules. The possible product mix up has happened in the production plant of this contract manufacturer. Burana-Caps capsules are packaged at Orion's own plant in Salo, Finland. No foreign capsules have been detected on the packaging line by the Salo plant's continuous automatic quality control system.
Since it is not known for certain that foreign capsules have not ended up in packages of Orion's Burana-Caps, Orion recalls Burana-Caps capsules from consumers as an extra precautionary measure.
Orion is not aware of any incidents of foreign capsules detected in the Burana-Caps package by the consumers. The issue concerns only Burana Caps capsules and not the other products in the Burana product family.
Consumers are advised to return both opened and unopened Burana-Caps packages to the nearest pharmacy, from where they will be returned to Orion. Customers will be compensated the price of the purchased Burana-Caps package.
Orion's contract manufacturer Catalent is a major global manufacturer and concentrates on the manufacture of softgel capsules among other products. Catalent supplies products to many different pharmaceutical companies.
Orion has reported this event to Fimea, and continues cooperation with it.
Further information on Orion website: www.orion.fi/buranacapsinformation
Vice President, Quality Management, Orion Corporation
tel. +358 (0)50 966 2811
Terhi Ormio / media contacts
Vice President, Communications, Orion Corporation
tel. +358 (0)50 966 4646
Orionintie 1A, FI-02101 Espoo, Finland
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion developes inhaled Easyhaler® pulmonary drugs.
Orion's net sales in 2014 amounted to EUR 1,015 million, and the company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ Helsinki.