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Rosselkhoznadzor reveals violations in foreign-made animal vaccines

According to the Regional Office of Rosselkhoznadzor for the Novosibirsk and Tomsk regions, quality control of medicinal products for veterinary use revealed inconsistencies in three foreign-made animal vaccines.

Rosselkhoznadzor reveals violations in foreign-made animal vaccines
Photo by Alexander Plonsky /V&L

This implies, in particular, Reomun-3, the inactivated emulsified vaccine against avian reovirus tenosynovitis (serial number 103-273, date of expiry: 9/12/2024). This product is produced by the Biomune Company (USA). The inconsistencies were found in values of “activity (activity, strain S1122)” and “activity (activity, strain SS412)”.

Inconsistencies in safety values were detected in the Litergard LT-C vaccine for the prevention of scours in neonatal pigs (serial number 585990, date of expiry: 01/23/2024). The product is manufactured by Zoetis LLC (USA).

Quality control issues were also revealed in Sevak Flu H9 K, the Hungarian inactivated vaccine against avian influenza (serial number 011LG1NB, date of expiry: 09/21/2024). This product is manufactured by Ceva-Phylaxia Veterinary Biological Company, Ltd. The inconsistencies were revealed in “emulsion stability” values.

Besides that, the nonconforming pH levels were revealed in the Belgian product Kombitrim 240 (serial number 4014501, date of expiration: June 2026). This antimicrobial veterinary drug is intended for the treatment of gastrointestinal diseases, genitourinary disorders, respiratory diseases, and bacterial joint and skin inflammations in animals. The drug is produced by Kela N.V.

“In accordance with paragraph 7 of Article 9 of Federal Law No. 61-FZ of April 12, 2010 “On the Circulation of Medicines,” the circulation of the abovementioned batches of medicinal products for veterinary use has been suspended,” the Rosselkhoznadzor said.

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English version, 3 Apr 2023 21:16
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