NDC 0404-9971
Sterile Water 1 mL per 1 mL injection
On the label: Henry Schein, Inc.. It's repackaged: Henry Schein, Inc. rebottles it from Hospira, Inc.'s NDC 0409-4887.
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
- May 3, 2021 · Class II · Pfizer Inc.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Lots: Lot DN9185
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Water: every company that makes it
- Form
- injection, intramuscular; intravenous; subcutaneous
- Strength
- 1 mL per 1 mL
- Approval
- NDA NDA018801
- On the market since
- Jan 10, 2022
- Package NDCs
0404-9971-00- Official label
- DailyMed (National Library of Medicine), updated Nov 7, 2025
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