July 25, 2000Sodium Edecrin Recalled by Merck
Point, PA (SafetyAlerts) - The Food
and Drug Administration (FDA) today reported that Merck and Company is conducting a recall
of Sodium Edecrin because of pH failure (six month stability).
Sodium Edecrin(r) Intravenous (Ethacrynate sodium), 50 mg, single dose vial, Rx indicated
for the treatment of edema. NDC #0006-3620-50.
Recall #D-435-0. Class III
Lot Numbers: 1398J EXP 6/01, 0564K EXP 8/01, 0462K EXP 9/01.
Merck and Company, West Point, Pennsylvania.
Manufacturer, by letter dated June 20, 2000. Firm-initiated recall ongoing. This is
the first public notice issued by the FDA.
Nationwide, Germany, and Israel.
16,712 units were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafeMail subscribers July 25,
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