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In August 2002, the BCG vaccine used in Finland was discontinued by the manufacturer after factory inspectors were dissatisfied with the manufacturing process. Finland switched to a Danish-strain BCG vaccine that did not have marketing authorization in Finland. Despite a lack of marketing authorization, the vaccine was offered and recommended to all Finnish newborns (circa 55,000–60,000 per year), and parents were not told the vaccine had no marketing authorization, as required by Finnish and European Union legislation. The vaccine was injected into the thigh of newborns, despite clear manufacturer instructions that it should be administered to the upper arm, and despite the manufacturer's warning that injecting into a lower limb was associated with a greater number of adverse effects.