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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 25, 1998

PRODUCT
Epinephrine Injection, USP 1:1000 (1mg/ml), 1
mL ampule, sterile, Rx, intramuscular or
subcutaneous liquid injection, preservative
free. Packaged in boxes of 25 x 1 mL ampules.
A sympathetic, vaso-constricting, ommetic drug
commonly used to relieve respiratory distress
due to bronchospasm, to provide rapid relief
of hypersensitivity reactions to drugs and
other allergens, and to prolong action of
infiltration anesthetics. May restore cardiac
rhythm. NDC# 0517-1071-25.

Recall #D-076-8.

CODE

Lot Numbers: 6487 EXP 1/98, 6654 EXP 2/98,
6862 EXP 5/98, 7278 EXP 10/98, 7414 EXP 11/98,
7415 EXP 11/98, 7424 EXP 11/98, 7471 EXP
12/98, 7659 EXP 2/99, 7728 EXP 3/99, 7783 EXP
4/99, 6738 EXP 3/98, 6972 EXP 6/98, 7040 EXP
7/98 7126 EXP 8/98.

MANUFACTURER

American Regent Laboratories, Inc., Shirley,
New York.

RECALLED BY

Manufacturer, by letter on January 23, 1998,
followed by telephone. Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

715,575 ampules were distributed.

REASON

Discoloration - Product fails color and
clarity specifications.

 

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.