Batch Recall Notice for Veterinary Medicine Zerofen 22 % Granules, VPA 10987/140/001

Notice type: Recall

Date: 05/08/2022

One batch of the veterinary medicine Zerofen 22 % Granules, VPA 10987/140/001, is being recalled by Chanelle Pharma with immediate effect.

This recall is going to veterinarian, retailer, companion animal medicine licence holder and licenced merchant level.

The reason for the recall: Below specification results for the active substance, fenbendazole, were identified during stability studies. Subsequently, there is a risk that units from the batch may not have the intended therapeutic effect.



Product name or type:
Zerofen 22 % Granules


Reference:
QDR-V-22-024


Authorisation Number:
VPA 10987/140/001


Serial Or Batch Number And Expiry Date:

Batch number: J37541

Expiry date: 07 2024



Authorisation Holder:

Chanelle Pharmaceuticals Manufacturing Limited



Background Information Or Related Documents:

Please see a copy of the recall letter to veterinarians, retailers, companion animal medicine licence holders and licenced merchants.



Actions To Be Taken:

Veterinarians, retailers, companion animal medicine licence holders and licenced merchants who received units from the impacted batch will receive a recall letter by post. In this recall letter they are requested to:

  1. Check current inventory and immediately quarantine any units of the above batch.
  2. Contact Chanelle Pharmaceuticals Manufacturing Limited by telephone at (091) 870 130 or email at eigardiner@chanellegroup.ie to arrange for the return of impacted stock. Credit will be issued for all stock returned by 12 August 2022.
  3. If units from this batch have been supplied to any other veterinarian, retailer, companion animal medicine licence holder or licenced merchant, to forward a copy of the recall letter to them, and request they quarantine and return any unused units.


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