Recalls / Class I
Class ID-0117-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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).
- Affected lot / code info
- Lot # 10001088 exp 07/31/2024
Why it was recalled
Presence of Particulate Matter: Silicone
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 23,425 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-18
- FDA classified
- 2023-11-22
- Posted by FDA
- 2023-11-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0117-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.