Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter

[Posted 11/27/2013]

AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology

ISSUE: Baxter International Inc 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. 

BACKGROUND: 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 ß-blockers (beta blocker drugs); and for induction of intraoperative hypotension (low blood pressure during surgery).

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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/27/2013 - Firm Press Release - Baxter]