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 October 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: November 29, 2023
Initiation Date: October 18, 2023
Termination Date: N/A
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

Other recalls by Exela Pharma Sciences LLC

D-0620-2025 Class II — 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenou (July 30, 2025)
D-0303-2025 Class II — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Sing (March 7, 2025)
D-0116-2024 Class I — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Sing (October 18, 2023)
D-0118-2024 Class I — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL (October 18, 2023)
D-0080-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
D-0079-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (November 28, 2022)
D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
D-0022-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose (October 4, 2022)
D-0369-2022 Class II — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx (January 11, 2022)
D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx o (May 5, 2020)