Metogastron drops

Recall | Medicines | 29/04/2014

The marketing authorization holder informed its supplied customers by letter dated April 24, 2014, that due to the implementing decision C(2013)9846 in the context of the European risk assessment procedure according to Article 31 of Directive 2011/83/EC, the marketing authorization for "Metogastron 4 mg/ml Drops" will be withdrawn as of April 30, 2014.04.2014, as it is a liquid formulation for oral use with a concentration of more than 1 mg/ml of the active substance metoclopramide.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 thus a recall has been initiated.

Name of the medicinal product Metogastron 4 mg/ml - Tropfen
Marketing authorisation number(s) 1-19258
Marketing authorisation holder Hexal Pharma GmbH
Batch number(s) alle
Expiry date 09/03/2019
Classification of the recall3
BASG reference number INS - 640.001 - 1095

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