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Recall of Two Batches of Bovicef DC 250 mg Intramammary Suspension for Cattle to User Level in Ireland

Notice type: Recall

Date: 28/04/2017

  

Product name or type:
BOVICEF DC 250 mg Intramammary Suspension for Cattle

Reference:
QDR-V-17-011

Authorisation Number:
VPA10438/118/001

Active Substance:
Cefalonium dihydrate

Product Classification:
Prescription-only medicine

Serial Or Batch Number And Expiry Date:

Batch No.

Expiry date

AME027A

05/2019

ALS018A

07/2019

These two batches are the only batches of Bovicef DC 250 mg Intramammary Suspension for Cattle on the Irish market. They were first distributed in Ireland on 12th September 2016.

Prescription Required:
Yes

Recall Classification:
Wholesale, Veterinary Surgeon, Pharmacy, Co-Op and User Level

Target Audience:
Farmers / Users, Veterinary Surgeons, Pharmacists, Co-Ops and Wholesalers

Problem Or Issue:

The Health Products Regulatory Authority wishes to advise that two batches of the product Bovicef DC 250 mg Intramammary Suspension for Cattle are being recalled to user level in Ireland. 

The reason for the recall is that there is a possibility that a proportion of syringes in the two batches have not been sterilised.  While there is no evidence of lack of sterility of syringes, the batches are being recalled as a precautionary measure.

Recall letters have been issued by the distributor Bimeda to affected wholesalers, veterinary surgeons, pharmacies and Co-ops to which the batches were distributed.

Actions To Be Taken:


Information for Farmers / Users:

  • If you have been dispensed Bovicef DC 250 mg Intramammary Suspension for Cattle since 12th September 2016, please check all relevant areas of your farm for unused units.
  • If you are in possession of unused units of this product, please immediately physically segregate (i.e. quarantine) them and place them in an area which ensures that they are unavailable for use.
  • Please return the quarantined units to the veterinary surgeon / pharmacy / Co-Op which supplied the units to you without delay but within 10 days at the most.

 

Specific Information for Pharmacists, Veterinary Surgeons, Co-Ops:

  • 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 Bimeda.

     

  • We are requesting that units from the above-listed batches are recalled from farmers / users, so please perform the following actions:

     

    • Please check your dispensing records to identify customers to whom the product has been dispensed, from 12th September 2016 to date         
    • 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 Bimeda 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 Bimeda.

 

Unaffected stock of Bovicef DC is not available to order at this time.

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