May 31, 2000G.C. Hanford Mfg. Recalls
Certain Lots of Cefuroxime for Injection
NJ (SafetyAlerts) - The Food and
Drug Administration (FDA) today reported that G.C. Hanford Mfg. is recalling Cefuroxime
for Injection USP, 7.5 mg, IM/IV use, pharmacy bulk package for preparing IV admixtures,
Rx. because of Mislabeling - back panel of carton incorrectly declares 750 mg of
Cefuroxime activity per mL instead of the correct per 8mL.
The product can be identified by
codes: C2424 EXP 6/01, C2522 EXP 11/01, C2562 EXP 3/02.
FDA stated in its report that 9,150
vials of lot C2424 and 8,870 vials of lot C2522 were distributed to California, Florida,
Illinois, Louisiana, Massachusetts, Missouri, Minnesota, Mississippi, North Carolina, New
Jersey, New York, Pennsylvania, Tennessee, Texas, Utah, Washington state, Wisconsin, West
Virginia, international. None of lot C8760 left the control of Bristol-Myers Squibb.
This ongoing Class III recall
was initiated by the company, by letter dated May 9, 2000. This is the first public
notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-392-0
Notice of this product warning was
sent via email to SafeMail
subscribers May 31, 2000.
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