“Italy and Switzerland halted sales of Novartis AG’s (NOVN) flu vaccines after the company informed Italian authorities of a buildup of particles in the shots. Novartis said the products are safe.
Novartis didn’t provide enough information for officials to know the exact makeup of the proteins found in the Agrippal and Fluad shots, or their impact on the quality and safety of the vaccine, Italy’s Health Ministry said in a statement today. There have been no reports of illness because of the particles, officials said.
The vaccines present “quality defects that are potentially dangerous for public health,” the ministry said. Italy’s medicines agency AIFA “has established the need for further tests regarding the quality and security” of the vaccines, according to an earlier statement from the ministry.
The suspension adds to Novartis’s manufacturing woes. The company in January temporarily closed a factory in Lincoln, Nebraska, that makes the Excedrin headache remedy, the Lamisil gel for athlete’s foot, and Sentinel, an anti-flea product for dogs, because of quality concerns….”