The Food & Drug Administration (FDA) on January 23 announced the expansion by Baxter (Deerfield, Illinois) of its recall of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection to include a second lot (NC 109123). Lot NC 109925 was recalled in November 2017.
The recall was initiated because of the potential presence of particulate matter consistent with polyethylene. The particulate matter may have entered the solution during the manufacturing process.
The affected lots were distributed between 7-21-2017 and 10-2-2017.
Posted 11/15/2017] AUDIENCE: Pharmacy, Cardiology, Risk Manager ISSUE: Baxter International announced it is voluntarily recalling one lot of 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.