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U.S. Department of Health and Human Services

Drugs

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Recall of Denileukin diftitox, Ontak - (Seragen, Inc) - 2/14/2003

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.

 


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