RevitaCAM 5 mg/ml, spray for application in the oral cavity for dogs
Veterinary Medicines
|
11/12/2013
In a letter dated December 9, 2013, the distributor informed its customers that in some cases the wrong pump sizes were included in batch EDEG-2.Packages of the 6 ml glass vials could contain pumps for the 33 ml vials, which could result in a 3.1 to 6.3-fold overdose during one application. In further investigations, particles were detected in 2 batches (EKFE and EKFE-1), which, however, were not marketed in Austria. Therefore, for safety reasons, the marketing authorization holder recalls all possibly affected batches of RevitaCAM 5 mg/ml, spray for application in the oral cavity for dogs.
| Name of the medicinal product | RevitaCAM 5 mg/ml, Spray zur Anwendung in der Mundhöhle für Hunde |
|---|---|
| Marketing authorisation number(s) | EU-2/12/138/001 (6 ml), EU-2/12/138/002 (11 ml), EU-2/12/138/003 (33 ml) |
| Marketing authorisation holder | Abbott Laboratories Ltd, UK Vertrieb und Durchführung Rückruf: Vana GmbH, AT |
| Batch number(s) | EDEG-2 (6 ml), EDEG-3 (11 ml) EFFW (33 ml) |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0954 |
Further inquiry note
Page last modified:
12/07/2022