Exela Pharma Sciences recalls 100 mL Midazolam vials due to silicone particulate matter. This may cause serious reactions if injected. Contact for return instructions.
Presence of Particulate Matter: Silicone
Exela Pharma Sciences is recalling 100 mL Midazolam injection vials that may contain silicone particles. Using these vials could lead to serious health issues if the particles enter the bloodstream.
Silicone particles in the injection vials could enter the bloodstream during administration, potentially causing serious reactions like allergic responses or tissue damage. This hazard occurs because the particles are not visible to the naked eye and may be present in the solution.
Healthcare professionals who use these vials for intravenous medication administration. Patients receiving this medication under medical supervision are at risk if the vials are used without proper checks.
Check for vials labeled 'Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton'. The product was manufactured with lot number 10001088 and expires July 31, 2024.
Immediately stop using the recalled vials as they may contain silicone particles that could cause serious health issues.
No, the product contains silicone particles that could cause serious health issues if injected. Do not use these vials.
Look for vials labeled 'Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton' with lot number 10001088.
Immediately stop using the vials and contact Exela Pharma Sciences for return instructions.
We’ve drafted a message you can send Exela to request your refund or repair — edit it as you like.
Subject: Recall D-0117-2024 — Exela Exela Hello, I own a Exela that is covered by recall D-0117-2024 from Exela. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
