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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 18, 1998

PRODUCT
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
surgery.

Recall #D-099-8.

CODE

100ml vials Lot# 7JAB, EXP 6/99
100ml vials Lot# 7LAC, EXP 6/99
200ml vials Lot# 7JFB, EXP 7/99.

MANUFACTURER

Bayer AG, Leverkusen, Germany.

RECALLED BY

Bayer Pharmaceutical Division, West Haven,
Connecticut (labeler), by letter dated
February 26, 1998. Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

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.

REASON

Foreign particulate - One vial was found to
contain a birch tree seed.

 

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.