Drugs & medicalClass II

Exela Pharma Sciences LLC recalls 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,…

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Read the official notice →
Date
2025-09-17
Country
United States
Brand
Exela Pharma Sciences
Product
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…
Classification
Class II
Units
Nationwide in the USA
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Exela Pharma Sciences recalls

  1. 2025-04-02
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  3. 2023-11-29
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  5. 2022-12-21
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    Exela Pharma Sciences LLC recalls 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…

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    FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →
  7. 2022-11-02
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    Exela Pharma Sciences LLC recalls 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,…

    Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

    FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →
  9. 2022-01-19
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All 6 Exela Pharma Sciences recalls →

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    FDA · DeviceO&M HALYARD INCWorldwide - US Nationwide distribution in the states of GA, AL, PA and the…Official notice →
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