Baxter International Inc has voluntarily recall with the knowledge of the U.S. Food and Drug Administration batches of the drug - Nexterone Injection (amiodarone HCl) 150 mg/100 mL Premixed Injection,). This particular recall affected batch of the drug was
The recall is due to sterile particulate matter consisted with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.The extent and severity of harm from this substance 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.
This recall is an expanded recall and it involves
Anyone with the batch to stop distribution immediately.Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.
Source and further details; click recall of batches of Nexterone Injection
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