Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Reason for recall: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Recall initiated: 20221128
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated