August 16, 2000Cortef Oral Suspension Recalled
MI (SafetyAlerts) - The Food and
Drug Administration (FDA) stated in a report released yesterday that Pharmacia Corporation
is conducting a recall of its Cortef Oral Suspension because the product may not always be
effective for the treatment of congenital adrenal hyperplasia.
This is the first public notice of
this Class II
recall issued by the FDA.
Cortef(r) Oral Suspension (hydrocortisone cypionate) 10 mg/5mL, in 4 fluid ounce units.
Lot numbers: 62CAT, 63CAT, 64CAT, 23CRW, 24CRW, 04CJX, 05CJX, 19DAJ, 98DXA and 91DTM.
Pharmacia Corporation, Kalamazoo, Michigan.
Manufacturer, by letter dated July 18, 2000. Firm-initiated recall ongoing.
Nationwide, Belgium, Canada, Chile, Ireland, United Kingdom, Uruguay.
144,357 bottles were distributed.
Questions concerning these recalls may be directed
to the FDA at 1-888-INFO-FDA.
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