Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
" "
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999

E.M.T.-Rx Recalls Heparin Sodium

Raleigh, NC (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that E.M.T.-Rx is recalling Heparin Sodium because of mislabeling.  The label states heparin concentration at 100 unit/mL while manufacturing records indicate concentration at 10 units/mL.

PRODUCT
Heparin Sodium 100 units/mL in 0.9% Sodium Chloride 5 mL fill in a 12 mL syringe. The pre-filled heparin syringe is not intended to provide any therapeutic value.

Recall #D-264-9.

CODE
Lot numbers: 990202A and 990202B.

MANUFACTURER
E.M.T.-Rx, Raleigh, North Carolina.

RECALLED BY
Manufacturer, by telephone on May 26, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
10,440 units 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.