Problem Or Issue:
The Health Products Regulatory Authority wishes to advise that one batch of Carprieve 5%w/v Small Animal Solution for Injection is being recalled to veterinary surgeon level in Ireland.
The reason for the recall is a media fill simulation failure in the suite where the batch was manufactured. While there is no evidence of lack of sterility of the batch, sterility cannot be assured and the batch is now being recalled as a precautionary measure.
Recall letters have been issued by Norbrook to affected wholesalers, veterinary surgeons and to which the batch was distributed.
Actions To Be Taken:
Specific Information for Veterinary Surgeons
Actions to be taken:
- Please check all relevant areas of your facility for the batch listed in Table 1.
- Immediately physically quarantine any units from the batch which you have in your possession.
- Please contact Norbrook to arrange uplift of the quarantined stock.
Specific Information for Wholesalers:
- Please immediately quarantine any units from the batch listed in Table 1 which you have in your possession.
- Please contact Norbrook to arrange uplift of the quarantined stock.
Unaffected stock of these products is not currently available to order.