|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 18, 1998
Bayer, Trasylol (Aprotinin Injection) Sterile
Solution, 10,000 K.I.I./mL (1.4 mg/mL), Single
Dose Vial, 100ml, NDC 0026-8196-36, 200ml, NDC
0026-8197-63, Rx indicated for prophylactic
use to reduce perioperative blood loss and the
need for a blood transfusion in patients
undergoing cardiopulmonary bypass in the
course of repeat coronary artery bypass graft
100ml vials Lot# 7JAB, EXP 6/99
100ml vials Lot# 7LAC, EXP 6/99
200ml vials Lot# 7JFB, EXP 7/99.
Bayer AG, Leverkusen, Germany.
Bayer Pharmaceutical Division, West Haven,
Connecticut (labeler), by letter dated
February 26, 1998. Firm-initiated recall
Nationwide and international.
US Lot # 7JAB (Bayer Germany 965863K) 13,980
Vials released 11/21/97.
US Lot # 7LAC (Bayer Germany 965863K) 15,942
Vials released 1/9/98.
US Lot # 7JFB (Bayer Germany 967050E) 8,436
Vials released 11/24/97.
Foreign particulate - One vial was found to
contain a birch tree seed.