FDA Recall D-0117-2024

Exela Pharma Sciences LLC · Lenoir, NC

Class I — life-threatening Ongoing 939 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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).

Lot / code: Lot # 10001088 exp 07/31/2024

Quantity: 23,425 vials

Reason for recall

Presence of Particulate Matter: Silicone

Recall record

Recall number: D-0117-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2023-10-18
Classified by FDA Center: 2023-11-22
FDA published: 2023-11-29
Recalling firm: Exela Pharma Sciences LLC
Firm location: Lenoir, NC

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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