Problem Or Issue:
The Health Products Regulatory Authority wishes to advise that one batch of the product Bovaclox Milking Cow Intramammary Suspension is being recalled to user level in Ireland.
The reason for the recall is the identification of agglomeration within units of this batch. This has led to reports of difficulty in administering the product and creates the potential for increased residues and an extended withdrawal period.
Recall letters have been issued by the distributor Norbrook to affected wholesalers, veterinary surgeons, pharmacies and licensed merchants to which the batch was distributed.
Actions To Be Taken:
Information for Farmers / Users:
- If you have been dispensed Bovaclox Milking Cow Intramammary Suspension since 11th December 2017, please check all relevant areas of your farm for any unused units of batch number 7461-20D.
- If you are in possession of unused units from this batch, please immediately physically segregate (i.e. quarantine) and place those units in an area which ensures that they are unavailable for use.
- Please return the quarantined units to the veterinary surgeon / pharmacy / licensed merchant which supplied the units to you without delay but within 10 days at the most.
Specific Information for Pharmacists, Veterinary Surgeons, Licensed Merchants:
- Please check all relevant areas of your facility for units of batch number 7461-20D.
- Immediately physically quarantine any units which you have in your possession.
- Quarantined units will be uplifted by Norbrook.
- We are requesting that units from batch number 7461-20D are recalled from farmers / users, so please perform the following actions:
- Please check your dispensing records to identify customers to whom the batch has been dispensed since 11th Dec 2017. (The first date of distribution of this batch to the Irish market was 11th Dec 2017)
- Please endeavour to contact those customers by telephone, to ascertain if they have any remaining unused units from the affected batches. If units are identified by customers, please request that they return the units to you at their earliest opportunity but within 10 days at the most.
- Please quarantine any units returned to you by farmers / users and contact Norbrook to arrange their uplift.
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 Norbrook.
Unaffected stock of Bovaclox Milking Cow Intramammary Suspension is not currently available to order.