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SafetyAlerts
September 2, 2003

Abbott Labs Has Recalled INFANT 4.2% Sodium Bicarbonate

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
INFANT 4.2% Sodium Bicarbonate Injection, USP, 5 mEq (0.5 mEq/mL), 10 mL unit of use syringe, LifeShield, Glass Abboject, Rx only. Recall D-297-3.

CODE
Lot number 95-257-DK, Expiration date December 1, 2004.

RECALLING FIRM/MANUFACTURER
Abbott Labs, North Chicago, IL, by letters on July 11, 2003. Firm initiated recall is ongoing.

REASON
Mispacked; A correctly labeled vial of 10% Calcium Chloride Injection, USP was incorrectly packed in a carton labeled as Infant 4.2% Sodium Bicarbonate Injection, USP.

VOLUME OF PRODUCT IN COMMERCE
45,800 syringes.

DISTRIBUTION
Nationwide and Canada
.

 
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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.