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U.S. Department of Health and Human Services

Drugs

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Voluntary Recall of Dornase alfa (Pulmozyme) - (Genentech, Inc.) - 10/11/2000

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.