No foreign capsules have been detected in packages of Orion's Burana-Caps. Nevertheless, Orion recalled Burana-Caps 400 mg capsules from customers on 24 November 2015 as an extra precaution. The reason for the recall is individual observations where foreign capsules were mixed up in the production process of Orion's contract manufacturer Catalent's plant in France. The observations do not involve Orion's Burana-Caps but other capsules manufactured at the plant. No other products are delivered to Orion from this plant.
Foreign capsules were detected by the contract manufacturer's quality control system. Capsules were mixed up in the plant's production process with different products manufactured at the plant.
The mix-up does not involve Orion's Burana-Caps capsules. They 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, nor have any packages been returned to Orion with foreign capsules.
Orion's recall concerns only Burana-Caps capsules and does not concern any other products in the Burana product family. No other products are delivered to Orion from Catalent's French plant.
Burana-Caps capsules are OK
"No foreign capsules have been detected in packages of Burana-Caps. The quality of the capsules meets all requirements. Nevertheless, in the interest of patient safety we have recalled all Burana-Caps products from their users as an extra precaution because of the deviations detected in the production process of our contract manufacturer," says Päivi Järvelä, Vice President for Quality Management.
The Burana-Caps 400 mg capsule is a red, oval and soft gelatin capsule that contains a clear viscous liquid. The capsules are approximately 15 mm long and approximately 10 mm wide. Each capsule has the marking BURANA. Images of the capsule and packaging can be found on Orion's website at www.orion.fi. Any foreign capsules are easy to detect with the human eye because their colour, shape, size or markings will be different from Burana-Caps capsules.
Orion has reported the case to the Finnish Medicines Agency Fimea and is co-operating closely with it.
Vice President, Quality Management, Orion Corporation
tel. +358 (0)50 966 2811
Vice President, Communications, Orion Corporation
tel. +358 (0)50 966 4646
Pekka Järvensivu, Medical Specialist, tel. +358 (0)10 426 3616
Orion Corporation, Orionintie 1A, FI-02101 Espoo