Drugs & medicalClass I

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…

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

Read the official notice →
Date
2022-12-21
Country
United States
Brand
Exela Pharma Sciences
Product
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:…
Classification
Class I
Units
Nationwide within the United States
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-09-17
  2. US
    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.

    FDA · DrugExela Pharma Sciences LLCNationwide in the USAOfficial notice →
  3. 2025-04-02
  4. US
  5. 2023-11-29
  6. US
  7. 2022-11-02
  8. US
    Drugs & medicalClass I

    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
  10. US
All 6 Exela Pharma Sciences recalls →

Other drugs & medical recalls in the United States

  1. 2022-12-21
  2. US
    Drugs & medicalClass III

    Camber Pharmaceuticals, Inc recalls Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc.,…

    Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

    FDA · DrugCamber Pharmaceuticals, IncUSA NationwideOfficial notice →
  3. US
    Drugs & medicalClass I

    BayCare Integrated Service Center, LLC /dba BayCare… recalls Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes…

    Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

    FDA · DrugBayCare Integrated Service Center, LLC /dba BayCare…BayCare Health System hospitals in FLOfficial notice →
  4. US
  5. US
  6. 2022-12-14
  7. US
    Drugs & medicalClass II

    Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

    The devices may be packaged with the wrong reamer size.

    FDA · DeviceArthrex, Inc.Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ,…Official notice →
  8. US
    Drugs & medicalClass II

    Medical Action Industries, Inc. 306 recalls Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV…

    The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.

    FDA · DeviceMedical Action Industries, Inc. 306Distribution was made to MN. There was no foreign/government/military…Official notice →
See all drugs & medical recalls →