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U.S. Department of Health and Human Services

Drugs

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Recall of Infliximab, Remicade - (Centocor, Inc) - 11/19/2002

DATE RECALL INITIATED:

November 19, 2002

LOT NUMBERS / EXPIRATION DATES:

02F053A   7/2004
02F103A   8/2004

MANUFACTURER:

Centocor, Inc
Malvern, PA

REASON:

In response to customer complaints associated with lack of vacuum in the vial, the manufacturer found that the recalled products exhibit a stoppering defect that may contribute to the high incidence of this occurrence.

 


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.