US warns Sanofi over flu shot plant problems
WASHINGTON (Reuters) – The U.S. Food and Drug
Administration has warned a Sanofi-Aventis unit over
manufacturing problems related to its FluZone flu vaccine,
agency officials said on Monday.
Some vaccine ingredients made at a Pennsylvania plant
failed sterility tests, the FDA said in a letter, but none
those batches were used in final vaccines, the agency said.
The problem is not expected to significantly affect
Sanofi’s ability to provide flu vaccine for the 2006-2007
influenza season, FDA officials said.
A Sanofi spokesman could not immediately be reached for
Sanofi shares were up 52 cents, or more than 1 percent, to
$49.22 in early afternoon trading on the New York Stock