Where it's 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 |
| Hospira, Inc. | McPherson, KS, United States | Tests it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
Recalls
- Sep 6, 2019 · Class II · Pfizer Inc.
Lack of Assurance of Sterility
Lots: Lot #: W20308, Exp. Dec 1, 2019
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, intramuscular; intravenous; subcutaneous
- Strength
- 1 mL per 1 mL
- Approval
- NDA NDA018802
- On the market since
- Apr 30, 2005
- Package NDCs
0409-3977-010409-3977-03- Official label
- DailyMed (National Library of Medicine), updated May 22, 2026
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