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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Scopolamine Hydrobromide Injection, USP, 0.4
mg/ml in 1 ml multiple dose vials.

Recall #D-073-8.

CODE

Lot #360116 EXP 2/28/99.

MANUFACTURER

Fujisawa USA, Inc., Grand Island, New York.

RECALLED BY

Fujisawa USA, Inc., Deerfield, Illinois, by
letter issued dated January 26, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

137,650 vials were distributed.

REASON

Subpotent (stability).

 

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.