The marketing authorization holder has informed its supplied customers in a letter dated April 15, 2016, that a possible non-sterility cannot be excluded and therefore a precautionary recall is being carried out.
This recall results from an inspection by the Spanish surveillance authority (AEMPS) at the manufacturer Inmunotek S. L., during which it was determined that the sterility of the parenteral allergen therapeutics manufactured there is not ensured. Pharmacies are requested to return stocks of the Clustoid line of preparations to "Roxall Medizin GmbH". After weighing the benefits and risks, physicians are responsible for deciding whether to continue treatments that have already been started.
|Name of the medicinal product
|CLUSTOID - Präparatelinie
(CLUSTOID Milben, CLUSTOID Cluster-Allergoid, CLUSTOID Bäume)
|Marketing authorisation number(s)
|(ALL-0073, ALL-0051, ALL-0072)
|Marketing authorisation holder
|Roxall Medizin GmbH
|Classification of the recall
|BASG reference number
|INS - 640.001 - 1692