NDC 64725-4887
Sterile Water 1 mL per 1 mL injection, solution
On the label: TYA Pharmaceuticals. It's repackaged: TYA Pharmaceuticals 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 |
Repackaging site
- TYA Pharmaceuticals, Location not on file · repackages it and relabels it
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, solution
- Strength
- 1 mL per 1 mL
- Approval
- NDA NDA018801
- On the market since
- Sep 15, 2011
- Package NDCs
64725-4887-1- Official label
- DailyMed (National Library of Medicine), updated Sep 15, 2011
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