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November 16, 2000

Bayer Corporation Recalls Trasylol

First public notice issued by FDA of 'completed recall'...

West Haven, CT (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Bayer Corporation is recalling certain Trasylol (aprotinin injection) because there of a lack of assurance of sterility.

This is the first public notice of this Class II issued by FDA.

PRODUCT
Trasylol (aprotinin injection), 10,000 K.I.U./mL, 100 and 200 ml Sterile Solution, for intravenous infusion, Rx indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary artery bypass graft surgery.

NDC #0026-8196-36 (100 mL), NDC 0026-8197-63 (200 mL).

Recall #D-013-1.

CODE
Lot Numbers: ODIA EXP 01/02, OEHB EXP 01/02, OEFM EXP 01/02.

MANUFACTURER
Bayer AG, Leverkusen, Germany.

RECALLED BY
Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, by letter dated October 6, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION
Nationwide.

QUANTITY
29,514 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 SafetyAlerts subscribers November 16, 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.