Recalls Heparin Sodium
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999
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.
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
Lot numbers: 990202A and 990202B.
E.M.T.-Rx, Raleigh, North Carolina.
Manufacturer, by telephone on May 26, 1999. Firm-initiated recall ongoing.
10,440 units were distributed.