Baxter International Nexterone Injection Recall [US]


US FlagUS/Silver Spring: Baxter International Nexterone Injection Recall [US]Baxter International Inc. recalls certain batch/lots of Nexterone (Amiodarone HCl) 150 mg/100 mL Premixed Injection due to suspected particulate contamination and consequential risk of 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, all serious health and safety hazards. FDA: http://ht.ly/DUlX30gBAhx

Direct link: https://www.fda.gov/Safety/Recalls/ucm585155.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following drug products are subject to this recall:

  • Nexterone (Amiodarone HCl) Premixed Injection, 150 mg/100 mL, product code: 2G3451; batch/lot: NC109925; expiry date: 6/1/2019; NDC: 43066-150-10

Please consult the photograph above for details of the drug’s packaging, design and hospital presentation.

According to the FDA, Baxter International has recalled one (1) batch/lot of its Nexterone (Amiodarone HCl) 150 mg/100 mL Premixed Injection distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities due to the potential presence of particulate matter. This particulate matter may have entered the solution during the manufacturing process.

Nexterone is a prescription antiarrhythmic agent indicated used to treat recurring Ventricular Fibrillation and Hemodynamically Unstable Ventricular Tachycardia in patients refractory to other therapy.

In general, 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.

Specifically, 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.

==> Many of these side effects can in themselves, or in combination with existing or related side effects and/or conditions lead to serious, life-threatening and/or life-changing consequences including death.

As of the date of this recall, there have been no reports of adverse events associated with this suspected product contamination.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug adulteration or contamination. If in doubt about the safety of any drug, return it to your wholesaler or distributor for refund and/or replacement.

Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between 7:00 AM and 6:00 PM Central Time.

If you have any questions about this recall, please contact Baxter Corporate Product Surveillance at 1-800-437-5176, Monday through Friday, between 8:00 AM and 5:00 PM Central Time. Patients should contact their physician or other qualified healthcare provider if they have experienced any problems that may be related to using this product.

==> To see other recalls and notifications for products manufactured, marketed and or sold by Baxter International Inc., please search for “Baxter” using the Search Box at the top of this page.

___________________________________________________________

More information about this recall:
NDC: 43066-150-10
Recalls Direct RIN: 9455-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
==> Click on the “Like” button below.
E. & O. E.

___________________________________________________________

Advertisements
%d bloggers like this: