Recall: D-0022-2023

Class I - Dangerous

Class IClassification

2022-10-04Initiated

TerminatedStatus

Exela Pharma Sciences LLCFirm

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

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.