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Home > Recalled Products > Drugs > Particulate Matter > Nexterone Amiodarone HCl

Recall: Nexterone Amiodarone HCl

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On 2017-11-14, the FDA announced that Baxter International is conducting a recall on Amiodarone HCl due to a possible particulate matter. The recalled products were sold under the brand name(s) Nexterone during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 2 drugs recalls due to potential particulate matter, including vancomycin hydrochloride for injection, 0.9% sodium chloride injection, usp 1000 ml and more. Additionally, there have been 17 drug and medical device recalls due to other health hazards as well as 111 food recalls.

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NEXTERONE (amiodarone HCl) Premixed Injection, 150 mg/100 mL
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Baxter International
Phone: 800-437-5176

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Amiodarone HCl

Brand Name(s): Nexterone

Reason for Recall: Particulate matter

Official Recall Date: 2017-11-14


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Additional information provided by the FDA.gov:

Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection - distributed between 8/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities - due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process. Read More.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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