Carmubris (Ben Venue)
The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule of a single batch. As a precautionary measure, the marketing authorization holder is now recalling all still shelf-stable batches produced by this manufacturer.
|Name of the medicinal product||Carmubris - Trockenstechampulle mit Lösungsmittel|
|Marketing authorisation number(s)||1-21762|
|Marketing authorisation holder||Bristol-Myers Squibb GmbH|
|Batch number(s)||0C65692, 0F59559, 0J58810, 0L61433, 1C00815, 1F00519, 1G00376|
|Classification of the recall||2|
|BASG reference number||INS-640.001-0520|