European health officials are reporting that 13 deaths in Italy are not related causally related to the Fluad influenza vaccine, manufactured by Novartis. The Italian Medicines Agency (AIFA) had recalled two batches of the vaccine as a precaution.

AIFA, Italy’s drug regulator, has been working with the European Medicines Agency (EMA) to investigate those two batches for any possible issues. Eight of the 13 deaths happened just 24 hours after the Fluad vaccine was given, and nine of the people who died were older than 80.

Switzerland-based Novartis also said a causal relationship between the vaccine and the deaths has not been found. The company said in a statement that a review of the two recalled batches have confirmed they meet all production and quality standards. AIFA reports that the test results came back “completely negative.”

Fluad was approved in 1997 and was temporarily banned in 2012 by AIFA because unknown protein particles were found in one of the batches. More than 65 million doses of the vaccine have been distributed across the world since its approval.

The EMA suggests anyone with a home pack of the Fluad vaccine check for lot numbers 142,701 and 143,301 and ask their doctors for an alternative if they do have those recalled lots.

News, Vaccine Injury News Results of Novartis Flu Vaccine Analysis After Reports of 13 Deaths in Italy