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Rosselkhoznadzor Reports on Incompliances in Circulation of Veterinary Drugs

The Rosselkhoznadzor conducted quality control of medicinal products for veterinary use in public circulation and detected incompliances with the established vaccine potency requirements in samples of Rotagal immunobiological (Inactivated vaccine against rota-, coronaviral infection and colibacillosis in cattle) (Batch No. 66 02 20 01, expiry date 02.2022; Batch No. 65 01 20 01, expiry date 01.2022; Batch No. 62 01 20 01, expiry date 01.2022; Batch No. 42 10 19 01, expiry date 01.2021) manufactured by Pharmagal-Bio, s.r.o. (Slovakia).

The circulation of the concerned batches has been suspended.

In addition, due to repeated quality incompliances of the Rotagal samples (Inactivated vaccine against rota-, coronaviral infection and colibacillosis in cattle) collected from different batches, this vaccine is now subject to batch-to-batch sampling control.

This measure was introduced in accordance with Paragraph 35 of the Procedure for Sampling Control of Veterinary Medicinal Product Quality approved by Order of the Rosselkhoznadzor No. 605 of June 13, 2018.

More details are available on the Rosselkhoznadzor official website in the “Pharmacovigilance” section, “Quality Control of Medicinal Products for Veterinary Use” sub-section.

 

Dec 8, 2020

Categorys: Medicines