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.
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.