DATE RECALL INITIATED:
October 11, 2000
LOT NUMBER / EXPIRATION DATE:
1 DNA Way
South San Francisco, CA 94080-4990
An unapproved re-filtration step was utilized to remove metal particulates that had been found in the concentrated bulk drug substance.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.