Exela Pharma Sciences LLC: Drug Recall

Recall #D-0117-2024 · 10/18/2023

Class I: Dangerous

Recall Details

Recall Number: D-0117-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Exela Pharma Sciences LLC
Status: Ongoing
Date Initiated: 10/18/2023
Location: Lenoir, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,425 vials

Reason for Recall

Presence of Particulate Matter: Silicone

Product Description

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).

Distribution Pattern

Nationwide

Other Recalls by Exela Pharma Sciences LLC

Class II: Risk 07/30/2025

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II: Risk 03/07/2025

Lack of Assurance of Sterility
Class I: Dangerous 10/18/2023

Presence of Particulate Matter: Silicone
Class I: Dangerous 10/18/2023

Presence of Particulate Matter: Silicone
Class I: Dangerous 11/28/2022

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

View all recalls by Exela Pharma Sciences LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.