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SafetyAlerts
July 25, 2000

Sodium Edecrin Recalled by Merck and Company

West 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).

PRODUCT
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

CODE
Lot Numbers: 1398J EXP 6/01, 0564K EXP 8/01, 0462K EXP 9/01.

MANUFACTURER
Merck and Company, West Point, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated June 20, 2000. Firm-initiated recall ongoing.  This is the first public notice issued by the FDA.

DISTRIBUTION
Nationwide, Germany, and Israel.

QUANTITY
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, 2000.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.