Paspertine drops

Recall | Medicines | 29/04/2014

The marketing authorization holder informed its supplied customers by letter dated April 28, 2014, that due to the implementing decision C(2013)9846 in the context of the European risk assessment procedure according to Article 31 Directive 2011/83/EC, the marketing authorization for "Paspertin 4mg/ml - Drops" will be revoked as of April 30, 2014.04.2014, as it is a liquid formulation for oral use with a concentration of more than 1 mg/ml of the active substance metoclopramide. Accordingly, the product may no longer be marketed in Austria at this time and a recall has therefore been initiated.

Name of the medicinal product Paspertin 4 mg/ml -Tropfen
Marketing authorisation number(s) 14.204
Marketing authorisation holder Abbott GmbH
Batch number(s) Alle
Classification of the recall3
BASG reference number INS - 640.001 - 1093

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