Laboratories Recalls Amicar Syrup
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
July 7, 1999
Pearl River, NY (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Lederle Laboratories is recalling Amicar Syrup
25% (Aminocaproic Acid) because of USP antimicrobial effectiveness test failure
Amicar Syrup 25% (Aminocaproic Acid), each teaspoon
(5mL) contains 1.25 g Aminocaproic Acid, in 16 fluid ounce bottles, Rx useful in enhancing
hemostasis when fibrinolysis contributes to bleeding. NDC # 58406-611-90.
Lot numbers: 452-657 EXP 1/2001, 452-658 EXP 1/2001, 452-659 EXP 1/2001, 452-660 EXP
Lederle Laboratories, Pearl River, New York.
Immunex Corporation, Seattle, Washington, by letter during the week of May 17, 1999.
Firm-initiated recall ongoing.
2,888 bottles of lot 452-657
2,871 bottles of lot 452-658
1,514 bottles of lot 452-659
7 bottles of lot 452-660 were distributed.