Nitrolingual Pumpspray FDA Alerts

Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

December 27, 2021, Allegan, Michigan – Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.

Risk Statement: If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.

Padagis is notifying its distributors and customers by express package delivery service as well as electronic mail and is arranging for return of all recalled products. This recall is being directed at the consumer/user level. All customers, healthcare providers, and consumers are instructed to examine their inventory for Nitroglycerin Lingual Spray, 12g immediately and to quarantine, discontinue the distribution and use of, and return as directed all recalled lots of the product. Customers and healthcare providers are being provided recall information by Sedgwick Claims Management Services. All customers who have distributed this product to consumers have been requested to identify their customers and notify them immediately of this product recall. Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product. The necessary form to document product information, as well as other information, is available by contacting Sedgwick at padagis5665@sedgwick.com or 888-266-7912.

Patients with questions regarding this recall can contact 888-266-7912 M-F 8am – 5pm EST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product or any medical concerns.

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.

• Complete and submit the report Online
• Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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]