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 |
Recalls
- Mar 15, 2019 · Class I · Pfizer Inc.
Presence of Particulate Matter; glass particulates
Lots: Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019 - Jun 15, 2017 · Class II · Hospira a Pfizer Company
Lack of Sterility Assurance
Lots: Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019… - Mar 18, 2016 · Class I · Hospira Inc.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Lots: Lot # 56-148-EV, Exp 8/1/2017
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, intravenous
- Strength
- 84 mg per 1 mL
- Approval
- ANDA ANDA202432
- On the market since
- Oct 15, 2020
- Package NDCs
0409-6625-300409-6625-35- Official label
- DailyMed (National Library of Medicine), updated Apr 6, 2026
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