DEERFIELD, Ill., Nov 27, 2013 (BUSINESS WIRE) -- Baxter International Inc. announced today it has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism (blockage of blood vessels.) Other adverse events associated with injection of particulate matter include inflammation due to foreign material, particularly in the lungs, and local irritation of blood vessels.
There have been no reported adverse events associated with this issue to
date. The financial impact of this recall is not material to Baxter.
Nitroglycerin in 5% Dextrose Injection (Intravenous) is indicated for
treatment of peri-operative hypertension (treatment of high blood pressure
before, during and after surgery); for control of congestive heart failure in
the setting of acute myocardial infarction (during a new onset heart attack, a
weakness of the heart muscle may cause fluid to build up in the lungs and other
body tissues); for treatment of angina pectoris (chest pain) in patients who
have not responded to sublingual nitroglycerin and B-blockers (beta blocker
drugs); and for induction of intraoperative hypotension (low blood pressure
Baxter's Nitroglycerin in 5% Dextrose Injection is packaged in 250 mL glass
containers, with 12 glass containers per carton. The affected product code is
1A0694, and the affected lot number is G105197. Product affected by this recall
was distributed to healthcare centers and distributors in Colombia, Saudi Arabia
and the United States.
Baxter is notifying customers, who are being directed not to use product from
the recalled lot. Customers should locate and remove all affected product from
their facility. The affected lot was distributed to customers between January
17, 2013, and October 10, 2013. Unaffected lot numbers can continue to be used
according to the instructions for use. Affected product should be returned to
Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001 between the
hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are
available for replacement.
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA's MedWatch Adverse Event Reporting program
either online, by regular mail or by fax.