Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Drugs

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.

Page Last Updated: 10/04/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English