More Concern Over Heparin

February 4, 2008, 6:30AM. By Gordon Gibb

Round Lake, ILAnd now there is more concern over heparin, after another manufacturer has announced a voluntary recall of the product, this time in vials, as opposed to pre-filled syringes. While no deaths have been reported as of January 17th 2008, when the recall was announced, Baxter Healthcare Corporation is concerned enough about its product that it is pulling a number of lots from the market.

The recall announcement, filed with the US Food and Drug Administration (FDA) and residing on the FDA web site, is stamped URGENT PRODUCT RECALL.

Baxter Healthcare, based in Round Lake, has announced the recall of the following lots of heparin sodium injection vials:

Heparin Sodium Injection 1000 units/mL 10mL vial, Lot # 107054 and 117085

Heparin Sodium Injection 1000 units/mL 30mL vial, Lot# 047056, 097081, 107024, 107064, 107066, 107074, and 107111.

Baxter has initiated a voluntary recall of the affected vials of heparin sodium solution due to an increase in reports of adverse reactions including, but not limited to:

Generalized abdominal pain, upper abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, oral paresthesia, pharyngeal edema, restlessness, vomiting or retching, stomach discomfort, tachycardia, thirst, trismusm and unresponsiveness to stimuli.

The manufacturer reports in a release dated January 17th 2008 that it has launched an in-depth investigation into the affected product, in an effort to determine the root cause of the reactions, some of which appear rather severe.

It is not known, nor is it suggested that the reactions are due to some kind of bacterium, or whether the cause is linked to a manufacturing issue.

The manufacturer is advising doctors to segregate affected vials of the heparin sodium product, stop using the product immediately and return the vials to the manufacturer. Baxter is also asking anyone who serves as a wholesaler, dealer or distributor of the heparin sodium vials to immediately contact, and alert clients.

All of the affected products, and product lots carry an expiry of October 2009, with the exception of Lot # 097081, which carries an expiry date of September 2009.

All recalled product carry NDC # 0641245045 with the exception of Lot # 107054 and 117085, which carry an NDC # of 0641244045.

Baxter Healthcare Corporation is a trademark of Baxter International Inc.