Product Classification:
POM Prescription Only Medicine
Recall Classification:
Veterinary Surgeon, Wholesale
Target Audience:
Veterinary Surgeons, Wholesalers
Problem Or Issue:
The Health Products Regulatory Authority wishes to advise that two batches of Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs, VPA10782/015/001, labelled as Pharmasin 200 mg/ml Solution for injection for cattle and pigs, VM 30282/4028 are being recalled to Veterinary Surgeon level and Wholesale level in Ireland.
The reason for the recall is that the affected batches are incorrectly labelled and contain an incorrect package leaflet, which is in line with the UK marketing authorisation instead of the Irish marketing authorisation.
Recall letters have been issued by Huvepharma NV to affected veterinary surgeons to which the affected units were distributed.
Actions To Be Taken:
Please immediately quarantine any units of the affected batches which you have in your possession. You will be contacted by your wholesaler within 5 days to make arrangements for the quarantined units to be retrieved and replaced with unaffected units of this product.
If you have supplied any units from the affected batches to any other veterinary surgeon, clinic or other such party, please now contact that party and request that they return any unused units to you.
Specific Information for Veterinary Surgeons:
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If you have supplied any units from the affected batches to any other veterinary surgeon, clinic or other such party, please now contact that party, provide them with the recall letter and request that they return any unused units to you