FDA-Drug2022-11-02Class I
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
Exela Pharma Sciences LLC
Hazard
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Sold states
Nationwide within the United States
Affected count
2,123,040 vials
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief