Reported Nov 2, 2022 · Terminated
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20…
Exela Pharma Sciences LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exela Pharma Sciences LLC · 1245 Blowing Rock Blvd · Lenoir, NC · 28645-3618
Is this the product you have?
- 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 byExela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
- Lot codes and dates
Lot # : P0001370P0001371P0001372Exp. 10/2023P0001433P0001434 Exp. 11/2023P0001443P0001468P0001469P0001470P0001495P0001505P0001506P0001509P0001510P0001511P0001512 Exp. 12/2023P0001560P0001561P0001562P0001564P0001566P0001567P0001568 Exp. 01/2024P0001571P0001572P0001573P0001574P0001578P0001579P0001580P0001583P0001586P0001587P0001588P0001593P0001594P0001610P0001618P0001619P0001654 Exp. 02/2024P0001644P0001645P0001646P0001662P0001664 Exp. 03/2024P0001730 Exp. 05/2024
- Amount recalled
- 2,123,040 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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