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Voluntary Recall of Dornase alfa (Pulmozyme, Inhalation Solution)
DATE RECALL INITIATED:
October 11, 2000
LOT NUMBER / EXPIRATION DATE:
K9721A 10/2001
MANUFACTURER:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
REASON:
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.
Last Updated: 4/9/2002
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Updated: September 26, 2003 |
