← FDA ENFORCEMENT
D-0117-2024Class I

Exela Pharma Sciences LLC

Recalling firm
Exela Pharma Sciences LLC
Product type
Drug
Status
Ongoing
Report date
2023-11-29
Distribution
Nationwide
Firm state
NC
Product quantity
23,425 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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).

Code / lot info

Lot # 10001088 exp 07/31/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.