Recall | Medicines | 09/05/2016

The marketing authorization holder has informed its supplied customers in a letter dated 09.05.2016 that due to a technical error during production, there are residues of corrosive agents in the dry substance. Therefore, the two above mentioned batches of "Rifoldin 600mg dry substance for infusion preparation with solvent" are recalled as a precautionary measure. The recall will result in a restriction of distribution with this medicinal product. The marketing authorization holder is endeavoring to provide emergency supplies of unaffected batches in compliance with the Medicinal Products Importation Act 2010.

Name of the medicinal product Rifoldin 600 mg Trockensubstanz zur Infusionsbereitung mit Lösungsmittel
Marketing authorisation number(s) 17.370
Marketing authorisation holder sanofi-aventis GmbH
Batch number(s) A5548, A5549
Classification of the recall2
BASG reference number INS - 640.001 - 1718

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