Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
8.4% Sodium Bicarbonate Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Affected NDCs
72572-0740-01
72572-0740-20
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Bicarbonate NDC 72572-0740 |
84 mg/mL | Injection, Solution Intravenous |
Civica | Rx |
- Recalling firm
- Exela Pharma Sciences LLC
- NDC code
- 72572-740-20
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0023-2023 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Exela Pharma Sciences LLC
All 2022 recalls
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Other packaging defect recalls from 2022
All packaging defect recalls
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk
Susvimo (ranibizumab injection)
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
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