Exela Pharma Sciences, LLC
NDC labeler code: 51754
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Sodium bicarbonate6 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
- Verapamil hydrochloride2 products
- Cysteine hydrochlorideElcys · 2 products
- Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 2 products
- Sodium nitroprussideNipride Rtu · 2 products
- Caffeine citrate2 products
- Neostigmine methylsulfateBloxiverz · 1 product
- Tranexamic acidCyklokapron · 1 product
- Cupric chlorideCopper · 1 product
- Potassium acetate1 product
- Zinc chloride1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 31, 2022 | ANDA212071 | Cupric chloride CUPRIC CHLORIDE | Exela Pharma |
| May 21, 2021 | ANDA212007 | Zinc chloride ZINC CHLORIDE | Exela Pharma |
| June 20, 2019 | ANDA211091 | Sodium bicarbonate SODIUM BICARBONATE | Exela Pharma |
| April 16, 2019 | NDA210660 | Cysteine hydrochloride ELCYS | Exela Pharma |
| April 15, 2019 | NDA212020 | Tranexamic acid TRANEXAMIC ACID | Exela Pharma |
| July 11, 2018 | NDA210997 | Glycopyrrolate GLYRX-PF | Exela Pharma |
| March 8, 2017 | NDA209387 | Sodium nitroprusside NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | Exela Pharma |
| April 29, 2016 | NDA208289 | Ephedrine sulfate AKOVAZ | Exela Pharma |
| December 29, 2015 | ANDA206203 | Potassium acetate POTASSIUM ACETATE | Exela Pharma |
| May 31, 2013 | NDA204078 | Neostigmine methylsulfate BLOXIVERZ | Exela Pharma |
| September 21, 2006 | ANDA077233 | Caffeine citrate CAFFEINE CITRATE | Exela Pharma Science |
| September 21, 2006 | ANDA077304 | Caffeine citrate CAFFEINE CITRATE | Exela Pharma |
| March 30, 1984 | NDA018925 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Exela Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
July 30, 2025 · Class II · Ongoing · D-0620-2025 · Sodium bicarbonate
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-50
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March 7, 2025 · Class II · Ongoing · D-0303-2025 · Sodium bicarbonate
Lack of Assurance of Sterility
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial:
2023
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October 18, 2023 · Class I · Ongoing · D-0118-2024 · Cysteine hydrochloride
Presence of Particulate Matter: Silicone
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28
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October 18, 2023 · Class I · Ongoing · D-0116-2024 · Sodium bicarbonate
Presence of Particulate Matter: Silicone
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50
2022
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November 28, 2022 · Class I · Terminated · D-0079-2023 · Sodium bicarbonate
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
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 5
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October 4, 2022 · Class I · Terminated · D-0022-2023 · Sodium bicarbonate
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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 5
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January 11, 2022 · Class II · Terminated · D-0369-2022 · Sodium bicarbonate
Lack of Assurance of Sterility
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026