Carmubris (Ben Venue)

Replacement | Medicines | 27/08/2012

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

Further inquiry note