The United States: Baxter expands voluntary nationwide recall to include second lot of Nexterone Injection due to presence of particulate matter (English Only)
 
The US Food and Drug Administration (FDA) announces that, following the issuance of a voluntary recall dated 10 Nov 2017 of one lot of Nexterone (amiodarone HCl) 150mg/100mL Premixed Injection, Baxter International Inc. is expanding the recall to include a second lot (lot number NC109123 expiration date 5/2019) of Nexterone due to the potential presence of particulate matter. The affected lots were distributed between 21 Jul 2017 and 2 Oct 2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process. 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. 

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. To date, there have been no reports of adverse events associated with this issue. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm592678.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 15 Nov 2017. 

Ends/Thursday, Jan 18, 2018 
Issued at HKT 16:00 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/