US/Silver Spring:
Baxter International Inc. recalls certain batch/lots of Nexterone (Amiodarone HCl) 150 mg/100 mL Premixed Injection due to suspected particulate contamination and consequential risk of 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, all serious health and safety hazards. FDA: http://ht.ly/DUlX30gBAhx
Direct link: https://www.fda.gov/Safety/Recalls/ucm585155.htm
Additional information:
The US Food and Drug Administration (“FDA”) reports the following drug products are subject to this recall:
Filed under: Allergens & Intolerances, Anaphylaxis, Drugs, Laceration hazard, Particulates or other contamination, US FDA | Tagged: Anaphylaxis hazard, Baxter International Inc., drug, FDA, NDC: 43066-150-10, Nexterone, Recalls Direct RIN: 9455-2017, US Food and Drug Administration | Leave a comment »