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Synulox Lactating Cow – Advisory notice

Notice type: Advisory

Date: 20/01/2020

 Following an investigation, at the site of manufacture in another EU member state, of an issue around a lack of assurance in the Good Manufacturing Practice on one the active substances included in Synulox LC, the HPRA previously requested that batches of Synulox LC containing that ingredient be quarantined at wholesale level in Ireland. Following further consideration, the HPRA withdrew the quarantine notice on 20 January 2020. The net effect of the HPRA decision is to permit resumption of supply of Synulox LC on an as needed basis. The position is being kept under review, pending the availability of sufficient quantities of alternative lactating cow intramammary product over the coming period.

Product name or type:
Synulox Lactating Cow intramammary syringe

Reference:
Advisory notice Synulox LC

Authorisation Number:
VPA10387/075/001

Active Substance:
Amoxicillin, Clavulanic acid and Prednisolone

Product Classification:
Prescription only medicine

Manufacturer Or Supplier:
Zoetis

Serial Or Batch Number And Expiry Date:
All batches

Authorisation Holder:
Zoetis

Prescription Required:
Yes

Recall Classification:
Not applicable

Target Audience:
Veterinary practitioners, pharmacists and licensed merchants

Problem Or Issue:

Following a recent inspection of the manufacturer of one of the active substances in Synulox LC, a statement of non-compliance with good manufacturing practice was issued by the responsible inspectorate. That inspectorate advised that national competent authorities should consider the continued availability of any medicines containing that active substance based on whether sufficient alternatives exist on national markets. On foot of this advice, the HPRA, on 19 December 2019, requested that remaining stocks of Synulox LC be quarantined at wholesale level in Ireland pending further consideration. Subsequently, based on

  • an assessment of the quality and safety risks,
  • the availability of suitable alternatives, and
  • the animal health and welfare implications,

the HPRA withdrew the quarantine notice on 20 January 2020.

The net effect of this action is to permit supply of Synulox LC to the market on an as needed basis. 

The position is being kept under review by the HPRA, pending the availability of sufficient quantities of alternatives over the coming period.



Background Information Or Related Documents:
The HPRA is aware that, in one EU member state, Synulox LC has been recalled on a precautionary basis. The HPRA has been in discussion with the Department of Agriculture, Food and the Marine and with wholesalers and other manufacturers to ensure that sufficient intramammary antibiotics are available to meet the immediate needs of the Irish market. In relation to Synulox LC, the HPRA noted that both the active substance concerned by this issue, as well as finished product manufactured using the substance, comply with all manufacturing tests, and that no animal welfare issue has been identified from using the product. Based on these data, the HPRA assessment is that Synulox LC can continue to be supplied on an as needed basis, pending the availability of sufficient quantities of alternative products for the treatment of mastitis in lactating cows.

Actions To Be Taken:

In the interests of animal welfare, and having conducted a risk assessment, the HPRA is of the opinion that the national needs of animal welfare necessitate that the product continue to be supplied in Ireland on an as needed basis.

Veterinary practitioners may continue to prescribe Synulox LC where they deem appropriate for the treatment of mastitis in lactating cows. Pharmacists and Licensed Merchants may continue to dispense Synulox LC on foot of a veterinary prescription.

As is the position when an adverse event to a veterinary medicine is suspected, all such events should always be reported to the marketing authorisation holder (Zoetis, in this case) and/or to the HPRA.

Further Information:
The HPRA is continuing to monitor the availability of alternative intramammary lactating cow products and will update the situation based on developments.

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