May 24, 2000Merck and Company Inc. Recalls
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
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
Notice of this product warning was
sent via email to SafeMail
subscribers May 24, 2000.
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