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Allergy-Type Reactions Spur Recall of Baxter Heparin Vials

Submitted by jrlaw on Mar 9th, 2009

Heparin Sodium Injection Vials were recalled due to an increase in adverse Heparin reactions. Baxter has received 100 reports of negative reactions and one death that may be linked to the Baxter Heparin recall.

A variety of Heparin-caused reactions have been reported such as burning sensation, chest pain, abdominal pain, lowered blood pressure, diarrhea, dizziness, flushing, headache, hypotension, loss of consciousness, nausea, restlessness, vomiting, and stomach discomfort among others.

Nine lots of Heparin Sodium 1000 unit/mL for injection are included in the recall:

NDC# 0641244045, Lot #107054, Heparin 1000units/mL 10mL vial, expiration date 10/2009
NDC# 0641244045, Lot #117085, Heparin 1000units/mL 10mL vial, expiration date 11/2009
NDC# 0641245045, Lot #047056, Heparin 1000units/mL 30mL vial, expiration date 10/2008
NDC# 0641245045, Lot #097081, Heparin 1000units/mL 30mL vial, expiration date 09/2009
NDC# 0641245045, Lot #107024, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107064, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107066, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107074, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107111, Heparin 1000units/mL 30mL vial, expiration date 10/2009

The Baxter recall notice states no deaths have been connected to the recalled Heparin vials, however, a Florida TV station reported that one patient had died, and four others had suffered reactions that could be linked to the recalled products. State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility to discover if the patient’s death and the other reactions were linked to the recalled Heparin.