NDC 54868-4464
Sodium Chloride 9 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 0409-4888.
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 |
| Pfizer Healthcare India Private Limited | Anakapalli, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 18, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Jun 27, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Lots: Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, solution
- Strength
- 9 mg per 1 mL
- Approval
- NDA NDA018803
- On the market since
- Feb 8, 2001
- Package NDCs
54868-4464-0- Official label
- DailyMed (National Library of Medicine), updated Apr 19, 2012
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