EVICEL
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
Page last modified:
12/07/2022