Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Recalled December 21, 2022 · FDA recall D-0079-2023 · Exela Pharma Sciences
Hazard
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. · FDA Class I
Units
489,600 vials
Sold at
Nationwide within the United States
Description
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
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.
Manufacturer(s)
Exela Pharma Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →