NDC 54868-0617
Diazepam 5 mg per 1 mL injection, solution
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Hospira, Inc.'s NDC 0409-3213.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
| Hospira, Inc. | McPherson, KS, United States | Tests it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
Recalls
- Aug 16, 2013 · Class II · Hospira Inc.
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Lots: Lot: 23-505-EV, Exp. 11/14 - May 16, 2013 · Class II · Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Lots: 17-099-EV Exp 05/14 - Feb 26, 2013 · Class II · Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Lots: Lot 05-585-EV Exp. 05/13 - Aug 28, 2012 · Class II · Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Lots: Lot 17-100-EV and 17-399-EV
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diazepam: every company that makes it
- Form
- injection, solution
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA071583
- On the market since
- Feb 13, 2002
- Package NDCs
54868-0617-154868-0617-2- Official label
- DailyMed (National Library of Medicine), updated Apr 3, 2012
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