Replacement | Medicines | 14/11/2012

The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential reduction in efficacy does not pose a risk to patients, nevertheless a precautionary withdrawal of the affected batch was made.

Name of the medicinal product EVICEL Lösungen für Fibrinkleber
Marketing authorisation number(s) EU/1/08/473/002
Marketing authorisation holder Omrix Biopharmaceuticals S.A.

Vertrieb & Durchführung Rückruf:
Johnson & Johnson Medical Products GmbH
Batch number(s) R05F120
Classification of the recall 2

Further inquiry note