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Recall by Norbrook of one batch of Alamycin LA 200 mg/ml Solution for Injection and one batch of Vitesel Suspension for Injection to Veterinary Surgeon / Pharmacy level in Ireland

Notice type: Recall

Date: 06/12/2018

  

Product name or type:
: Alamycin LA 200 mg/ml Solution for Injection, Vitesel Suspension for Injection. Refer to Table 1

Reference:
QDR-V-18-117 and QDR-V-18-118

Active Substance:

Table 1

Product name

Authorisation number

Active substance

Batch number

Expiry date

Alamycin LA 200 mg/ml Solution for Injection

VPA10999/19/1

Oxytetracycline

8301-91B

Jul 2020

Vitesel Suspension for Injection

VPA10999/49/1

all-rac-α-Tocopheryl acetate

8313-92E

Feb 2020


Product Classification:
Wholesale, Veterinary Surgeon and Pharmacy

Target Audience:
Veterinary Surgeons, Pharmacists and Wholesalers

Problem Or Issue:

The Health Products Regulatory Authority wishes to advise that one batch of Alamycin LA 200 mg/ml Solution for Injection and one batch of Vitesel Suspension for Injection are being recalled to veterinary surgeon / pharmacy level in Ireland. 

The reason for the recall is due to a Media Fill Simulation failure in the suite where these batch was manufactured. While there is no evidence of lack of sterility of these batches, sterility cannot be assured and the batches are now being recalled as a precautionary measure

Recall letters have been issued by Norbrook to affected wholesalers, veterinary surgeons and pharmacies to which the batches were distributed.

Actions To Be Taken:

Specific Information for Veterinary Surgeons and Pharmacists

Actions to be taken:

  • Please check all relevant areas of your facility for the batches listed in Table 1.
  • Immediately physically quarantine any units from those batches 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 batches 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.

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