Product: Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Reason for recall: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Recall initiated: 20140616
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated