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Recall of one batch of Alfaxan Multidose 10mg/ml Solution for Injection for Dogs, Cats and Pet Rabbits, VPA10666/2/1 to Veterinary Surgeon level in Ireland

Notice type: Recall

Date: 16/07/2019

Product name or type:
Alfaxan Multidose 10mg/ml Solution for Injection for Dogs, Cats and Pet Rabbits

Reference:
QDR-V-19-031

Authorisation Number:
Refer to Table 1

Active Substance:
Refer to Table 1

Serial Or Batch Number And Expiry Date:
Refer to Table

Prescription Required:
Yes

Recall Classification:
Veterinary Surgeon

Target Audience:
Veterinary Surgeon

Problem Or Issue:

The Health Products Regulatory Authority wishes to advise that one batch of Alfaxan Multidose 10mg/ml Solution for Injection for Dogs, Cats and Pet Rabbits is being recalled to veterinary surgeon level in Ireland.

The reason for the recall is that during routine stability testing, particulates were detected in a number of units from batch no. 55523. Recall letters have been issued by Jurox to veterinary surgeons to whom the batch was distributed.

Background Information Or Related Documents:

Table 1

Product name	Authorisation number	Active substance	Batch number	Expiry date
Alfaxan Multidose 10mg/ml Sol. for Injection for dogs, cats and pet rabbits	VPA10666/002/0001	Alfaxalone	55523	16/04/21

Further Information:

Specific Information for Veterinary Surgeons:

Actions to be taken:

•Please check all relevant areas of your facility to establish if you have any units from batch no. 55523.

•Immediately physically quarantine any units from the batch which you have in your possession.

•Please contact your wholesaler to arrange uplift of the quarantined stock.

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