The Main Pharmaceutical Inspectorate withdrew from the market one batch of vaccine against typhoid fever (Typhim Vi). The reason for the recall is that contamination is found in the pre-filled syringes.
The recall is for Typhim VI (Vaccinum febris typhoidis polysaccharidicum), 25 µg purified Salmonella typhi capsular polysaccharide (Vi) (Ty2 strain) / 0,5 ml, 0,5 ml, solution for injection in pre-filled syringe lot number: N1H782V and expiration date 08.2019. Marketing Authorization Holder: Sanofi Pasteur SA, France.
The research carried out at the NIPH-NIH confirmed that the sample of the above-mentioned medicinal product is inconsistent with the specifications of the MAH. Debris was visible in the naked eye in several pre-filled syringes.
The decision was made immediately enforceable.
The vaccine that prevents typhoid fever is recommended for people traveling to endemic regions, i.e. those where the disease occurs and affects a large part of the population. It should not be given to children under 2 years of age.
Typhoid fever is an infectious disease of the gastrointestinal tract, caused by Salmonella typhi bacteria. It is a gram negative bacterium. Only humans (carriers or sick people) are a reservoir of infection, while the contagious material is faeces, sometimes urine. The infection occurs through the ingestion, as a result of eating food and water contaminated with excrements of carriers and sick people. The disease is characterized by symptoms such as rash (so-called typhoid rubella), abdominal pain and high temperature. Its occurrence is spreading all over the world, and the greatest risk of infection is in countries with low levels of hygiene in food preparation.