Metoceolate 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 of Directive 2011/83/EC, the marketing authorization for "Metoceolate 4 mg/ml - Drops" will be revoked as of April 30, 2014.04.2014 is revoked, as it is a liquid formulation for oral use with a concentration of more than 1mg/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 Metoceolat 4 mg/ml –Tropfen
(Bezeichnung vor dem 05.12.2012 Metoclopramid Ceolat 4 mg/ml – Tropfen)
Marketing authorisation number(s) 1-31681
Marketing authorisation holder G.L. Pharma GmbH
Batch number(s) 3E611A, 4B609A (Metoceolat 4 mg/ml – Tropfen)
2M633A (Metoclopramid Ceolat 4 mg/ml – Tropfen)
Classification of the recall3
BASG reference number INS - 640.001 - 1094

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