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Recall of One Batch of Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats to Veterinary Surgeon Level in Ireland

Notice type: Recall

Date: 13/03/2018

Product name or type:
Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Reference:
QDR-V-18-017

Authorisation Number:
VPA 10445/1/1

Active Substance:
Oxytocin

Serial Or Batch Number And Expiry Date:

Batch No.	Expiry date
J2101-03	30/11/18

Authorisation Holder:
Bela-Pharm GmbH & Co. KG

Prescription Required:
Yes

Recall Classification:
Wholesale, Veterinary Surgeon

Target Audience:
Veterinary Surgeons, Wholesalers

Problem Or Issue:

The Health Products Regulatory Authority wishes to advise that one batch of the product Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats is being recalled to veterinary surgeon level in Ireland.

The reason for the recall is the potential for decreased levels of the preservative chlorobutanol hemihydrate in the batch. The recall is being taken for precautionary reasons.

Recall letters have been issued by the distributor Duggan Veterinary Supplies Ltd. to affected veterinary surgeons and wholesalers to which the batch was distributed.

Actions To Be Taken:

Specific Information for Veterinary Surgeons

Please check all relevant areas of your facility for units of the affected batches.
Immediately physically quarantine any units which you have in your possession.
Quarantined units will be uplifted by Duggan Veterinary Services Ltd.

Specific Information for Wholesalers:

Please immediately quarantine any units from the above referenced batches which you have in your possession.
Quarantined units will be uplifted by Duggan Veterinary Services Ltd.

Unaffected stock of Oxytobel 10 IU/ml Solution for Injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats is not available to order at this time.

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