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Recall of Dornase alfa (Pulmozyme)
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.
Last Updated: 4/5/2002
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Updated: September 26, 2003 |
