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SafetyAlerts
November 21, 2000

Pipracil® and Zosyn® Recalled

Philadelphia, 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.

PRODUCT
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, piperacillin/tazobactam-
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 Use;
c) Zosyn(r) 3.375 gram ADD-Vantage(r) vials (Sterile Piperacillin and Sodium Tazobactam Sodium), For IV Use.

Recall #D-020/022-1.

CODE
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.

MANUFACTURER
Lederle Piperacillin, Inc., Carolina, Puerto Rico.

RECALLED BY
Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania, by letter on October 13, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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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.