November 21, 2000Pipracil® and Zosyn® Recalled
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Wyeth-Ayerst Laboratories is recalling certain
vials of Pipracil® and Zosyn® because of vial breakage.
This is the first public notice of
this Class III
issued by FDA.
Pipracil, Rx indicated for the treatment of serious infections caused by
susceptible strains of designated organisms; Zosyn 3 gram/0.375 gram: indicated for the
treatment of patients with moderate to severe infections caused by peperacillin-resistant,
susceptible, beta-lactamase producing strains of designated microorganisms:
a) Pipracil(r) 3 gram
ADD-Vantage(r) vials (Piperacillin Sodium), For IV Use;
b) Pipracil(r) 4 gram ADD-Vantage(r) vials (Piperacillin Sodium), For IV
c) Zosyn(r) 3.375 gram ADD-Vantage(r) vials (Sterile Piperacillin and
Sodium Tazobactam Sodium), For IV Use.
Lot Numbers: a) 426-116 EXP 4/01; b) 426-149 EXP
6/01,464-675 EXP 2/02, 800-118 EXP 6/02; c) 800-048 EXP 4/03.
Lederle Piperacillin, Inc., Carolina, Puerto Rico.
Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania, by letter on October 13, 2000.
Firm-initiated recall ongoing.
Approximately 21,422 units were distributed between July 1999 - September 2000. (Pipracil
3 gram 5,022 units, Pipracil 4 gram 15,566 units and Zosyn 5, 424 units).
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 SafetyAlerts subscribers November
21, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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