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May 24, 2000

Merck and Company Inc. Recalls Urecholine(r) Injection

West Point, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Merck and Company, Inc., are conducting a recall of Urecholine(r) Injection (Bethanechol Chloride), 5.15 mg/mL, 1 mL injection, because of pH failure (at stability testing).

The Urecholine is a prescription for the treatment of acute post-operative/post-partum non-obstructive urinary retention, and for neurogenic atony of urinary bladder with retention. The product is coded with the Lot Numbers: 0019E EXP 3/01, 0947E EXP 3/01, 0327J EXP 8/01, 0346J EXP 8/01, 1323J EXP 8/01, 1324J EXP 8/01, 1374H EXP 8/01, 1606H EXP 8/01, 1898H EXP 8/01.

FDA stated in its report that 20,858 units were distributed nationwide, France, Australia, Italy, Sweden, Lebanon and South Africa.  The firm estimated that 600 units remained on market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter dated March 23, 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-358-0
NDC #07786-29-00

Notice of this product warning was sent via email to SafeMail subscribers May 24, 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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