|
Recall of Denileukin diftitox (Ontak)
DATE RECALL INITIATED:
February 24, 2003
LOT NUMBER / EXPIRATION DATE:
6ME11M 6/2003
MANUFACTURER:
Seragen, Inc
San Diego, CA
RECALLING FIRM:
Cardinal Health
Dublin, OH
REASON:
The recalling firm has discovered that one box of the recalled product, which is to be maintained in the frozen state, was returned to the facility unfrozen, and inadvertently redistributed. The manufacturer disclosed that this condition may cause the product to become subpotent. This recall is limited to only those products received from Cardinal Health between the dates of January 25, 2003 and February 21, 2003 and does not impact any quantity received outside of this time period. Establishments are instructed to quarantine any product in inventory and contact the recalling firm for return instructions.
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: 3/3/2003
 Back
to Top 
Back to Index
Updated: September 26, 2003 |
