Baxter International has voluntarily recalled one lot of the antiarrhythmic drug amiodarone HCl (Nexterone) due to the potential presence of particulate matter that may have entered the solution during the manufacturing process[1].
The recall affects the following lot:
| Product code | Product description | Lot number | Exp date | NDC |
|---|---|---|---|---|
| 2G3451 | Nexterone (amiodarone HCl) premixed injection, 150/100mL | NC109925 | 6/1/2019 | 43066-150-10 |
The recalled lot was distributed between June 23 and October 2, 2017 in the US to wholesalers/distributors and healthcare facilities.
“The particulate matter was identified by Baxter during a stability study and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which Nexterone is packaged,” the FDA said in a safety alert posted November 15 on its website.
“Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune-system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization,” the FDA warned.
The FDA said anyone with existing inventory of the recalled lot should immediately stop using and distributing it and quarantine the product.
The recalled product may be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7:00 AM and 6:00 PM Central Time.
Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8:00 AM and 5:00 PM Central Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to this recall to MedWatch, the FDA’s safety information and adverse event reporting program.
For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
Tidak ada komentar:
Posting Komentar