Drug Enforcement D-0117-2024

Presence of Particulate Matter: Silicone

Status

Ongoing

Classification

Class I

Report Date

November 29, 2023

Termination Date

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Product Information

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).
Product quantity
23,425 vials
Reason for recall
Presence of Particulate Matter: Silicone
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Exela Pharma Sciences LLC
Address
1245 Blowing Rock Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0117-2024
Event ID
93265
Recall initiation date
October 18, 2023
Center classification date
November 22, 2023
Code info
Lot # 10001088 exp 07/31/2024
More code info
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