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SafetyAlerts
September 10, 2003

Ortho Biotech Has Recalled Sporanox Injection Kit

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Sporanox Injection Kit (Itraconazole), 10mg/mL, 25mL ampule, One Unit Dose Ampule per kit, Rx only, NDC 50458-298-01 (kit). Recall # D-305-3.

CODE
02F03AIW (02/04); 02F04AIW (02/04); 02G01AZ7 (04/04); 02H02AZ7 (04/04); 02J01AZ7 (02/04) 02J02AZ7 (02/04); 02J03AZ7 (05/04); 02J03BZ7 (05/04) 02L02AZ7 (07/04); 02L03AZ7 (07/04); 02L04AZ7 (08/04).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho Biotech Products LP, Raritan, NJ, by letters on June 27, 2003.
Manufacturing Firm: Abbott Laboratories, North Chicago, IL. Firm initiated recall is ongoing.

REASON
Discoloration; incorrect connector piece included in the Abbott Microbore Extension Set/Kit may become discolored.

VOLUME OF PRODUCT IN COMMERCE
60,000 kits.

DISTRIBUTION
Nationwide, Germany and Israel
.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.