Home / Recalls / Exela Pharma Sciences LLC / D-0117-2024

D-0117-2024 Class I Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0117-2024 was initiated by Exela Pharma Sciences LLC on Oct 18, 2023 and is designated Class I. Reason for recall: Presence of Particulate Matter: Silicone The recall status is ongoing. Affected quantity: 23,425 vials.

Recall Details

Product Type: Drugs
Report Date: Nov 29, 2023
Initiation Date: Oct 18, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,425 vials

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).

Reason for Recall

Presence of Particulate Matter: Silicone

Distribution Pattern

Nationwide

Code Information

Lot # 10001088 exp 07/31/2024

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0117-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx… (May 5, 2020)