Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Recalls
- Dec 16, 2016 · Class II · Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specifications
Lots: Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017 - Sep 27, 2012 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lots: Lot 6003827, Exp. Date 04/2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Midazolam: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA075154
- On the market since
- Jul 10, 2000
- Package NDCs
63323-412-0263323-412-0363323-412-0563323-412-0663323-412-1063323-412-1363323-412-1863323-412-25- Official label
- DailyMed (National Library of Medicine), updated Jul 15, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?