Recall: Nexterone Nexterone 150mg/100ml Injection
On 2018-01-16, the FDA announced that Baxter International is conducting a recall on Nexterone 150mg/100ml Injection 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 5 drugs recalls due to potential unintended use, including clopidogrel tablets usp, 75 mg, ampicillin and sulbactam for injection usp and more. Additionally, there have been 10 drug and medical device recalls due to other health hazards as well as 115 food recalls.
Company Contact Information:
Name: Baxter International
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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: Nexterone 150mg/100ml injection
Brand Name(s): Nexterone
Reason for Recall: Presence of particulate matter
Official Recall Date: 2018-01-16
Additional information provided by the FDA.gov:
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. 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.