November 16, 2000Bayer Corporation Recalls
public notice issued by FDA of 'completed recall'...
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.
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
Lot Numbers: ODIA EXP 01/02, OEHB EXP 01/02, OEFM EXP 01/02.
Bayer AG, Leverkusen, Germany.
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.
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.
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