An immediate recall is in place for several intravenous (IV) medications due to the presence of particulate matter discovered by the FDA. The drugs used in medical facilities may cause serious health outcomes for patients. As of the writing of this notice, no adverse events have yet been reported.
SUMMARY
Date of Recall:
Announced: October 25, 2023
Public Notification: October 25, 2023
Name(s) of Drug:
84% Sodium Bicarbonate Injection, USP
Midazolam in 0.8% Sodium Chloride Injection
ELCYS (cysteine hydrochloride injection), USP
Company Name:
Exela Pharma Sciences, LLC
Brand Name:
Exela
Civica
Drug Indication:
Metabolic Acidosis
Medical Sedation
Nutritional Support
Product Description
The intravenous medications were distributed nationwide to health systems between January 2022 and September 2023. Each was marked accordingly with the label shown above. Vial sizes are indicated on the chart below.
Reason for Recall
During an inspection, particulate matter identified as silicone was noted in the samples.
Recall Impacts
Consumers who receive the medications via IV are at a high risk of developing stroke or other adverse health outcomes due to the particulate matter circulating in their bloodstream. Death may occur if the blood vessels of the heart, lungs, brain, or other organs become blocked.
Lot Information
Health system pharmacies and healthcare personnel should locate their stock of these medications and compare them with the chart below. Remove any stock that matches the drug name, strength, vial size, brand name, lot number, and expiration date from circulation and immediately submit a recall stock response form to Exela. Information on how to do so is listed below.
Brand
|
Product Description |
Vial
|
Lot Number |
Expiration Date |
| Exela
|
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001429 |
11/2023 |
| Exela | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001900 |
08/2024 |
|
Exela
|
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001902 |
08/2024 |
|
Exela |
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001903 |
09/2024 |
| Exela
|
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001909 |
09/2024 |
|
Civica |
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001912 |
08/2024 |
| Exela
|
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0001945 |
09/2024 |
|
Exela |
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0002002 |
11/2024 |
| Exela
|
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50mL |
50mL | P0002052 |
12/2024 |
|
Exela |
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100mL |
100mL | 10001088 |
07/2024 |
| Exela
|
ELCYS (cysteine hydrochloride injection), USP 500mg/10mL |
10mL | 10000798 |
03/2025
|
Have you found that medication in your stock is part of the recall? Here’s what you should do:
Health Systems
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Exela at (828) 341-6118 or use recall@exela.us to contact them via email.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Exela at (828) 341-6118 or use recall@exela.us to contact them via email. Notify them of any recalled batches that have already been shipped to hospital systems.
- Notify affected hospital systems of recalled batches that they have already received or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!