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U.S. Department of Health and Human Services

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Recall of Dornase alfa (Pulmozyme) - (Genentech, Inc) - 4/18/2001

DATE RECALL INITIATED:

April 18, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Dornase alfa, Pulmozyme, Inhalation Solution

N9700A 2/2003

MANUFACTURER:

Genentech, Inc.
San Francisco, CA

REASON:

Genentech, Inc., is recalling the above mentioned lot of Dornase alfa, Pulmozyme, Inhalation Solution after discovering that Pulmozyme ampules were damaged during manufacturing. An investigation conducted by the firm disclosed that a small number of the ampules exhibited a tiny puncture resulting in leakage of the product. Pulmozyme is indicated for use in the treatment of Cystic Fibrosis.

 


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.