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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
July 7, 1999

Lederle Laboratories Recalls Amicar Syrup

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 (stability).

PRODUCT
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.

Recall #D-261-9.

CODE
Lot numbers: 452-657 EXP 1/2001, 452-658 EXP 1/2001, 452-659 EXP 1/2001, 452-660 EXP 2/2001.

MANUFACTURER
Lederle Laboratories, Pearl River, New York.

RECALLED BY
Immunex Corporation, Seattle, Washington, by letter during the week of May 17, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 

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.