Recall of IV Medications Issued Due to the Presence of Particulates - MedWaste Management Recall of IV Medications Issued Due to the Presence of Particulates - MedWaste Management

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Exela Recall FDA, IV medications

Recall of IV Medications Issued Due to the Presence of Particulates

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

Exela Sodium Bicarbonate Injection
Exela Recall Sodium Bicarbonate Injection
Exela Recall Midazolam Injection
Exela Recall ELCYS Injection

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
Name
 
Product DescriptionVial
Size
Lot NumberExpiration Date
Exela 8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000142911/2023
Exela8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000190008/2024
Exela8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000190208/2024
Exela8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000190309/2024
Exela 8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000190909/2024
Civica8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000191208/2024
Exela 8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000194509/2024
Exela8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000200211/2024
Exela 8.4% Sodium Bicarbonate Injection, USP
50 mEq/50mL
50mLP000205212/2024
ExelaMidazolam in 0.8% Sodium Chloride Injection
100 mg/100mL
100mL1000108807/2024
Exela ELCYS (cysteine hydrochloride injection), USP
500mg/10mL
10mL1000079803/2025

FDA.gov

Have you found that medication in your stock is part of the recall? Here’s what you should do:

Health Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Exela at (828) 341-6118 or use recall@exela.us to contact them via email.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. 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.
  3. Notify affected hospital systems of recalled batches that they have already received or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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