Midazolam Injectable Recalled for Silicone Particulate Matter Contamination
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. No deaths or serious injuries have been reported, but particulate matter in injectable medications represents a significant safety concern.
Plain-English summary
Exela Pharma Sciences, LLC is recalling Midazolam in 0.8% Sodium Chloride Injection due to the presence of silicone particulate matter. The product is a sedative medication administered intravenously and is distributed as 100 mL single-dose vials.
The recall affects Lot #10001088 with an expiration date of July 31, 2024. Approximately 23,425 vials were distributed nationwide to healthcare facilities.
Healthcare providers and facilities that received this product lot should stop using it immediately and identify any patients who received doses from the affected vials. Any adverse health effects potentially related to this product should be reported to the FDA.
Patients who received Midazolam from the affected lot should consult their healthcare provider for guidance regarding any health concerns.
The recalled product
- 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…
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Injectable / IV Drug
- Hazard
- Affected units
- 23,425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 10001088 exp 07/31/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Exela Pharma Sciences LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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