Reported Nov 29, 2023 · Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1;…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and |
| 2 | 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL) |
| 3 | 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. |
- Lot codes and dates
a) P0001429EXP 11/30/2023 b) P0001900P0001902EXP 08/31/2024P0001903P0001909P0001945EXP 09/30/2024P0002002EXP 11/30/2024P0002052EXP 12/31/2024 c) P0001912EXP 08/31/2024
- Amount recalled
- 355,220 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Silicone
Using this product could cause serious injury, illness or death — stop using it now.
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