NDC 0487-6105
Sterile Water 1 mL per 1 mL injection
On the label: Nephron Pharmaceuticals Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nephron SC, LLC | West Columbia, SC, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyAug 22, 2025 · 26 inspections, 10 with FDA action |
Recalls
- Feb 23, 2023 · Class II · Nephron Sc Inc
CGMP Deviations: Potential product carryover.
Lots: Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023 - Jan 12, 2023 · Class II · Nephron Sc Inc
CGMP Deviations: potential for trace amounts of product carryover.
Lots: Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
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
- ANDA ANDA211222
- On the market since
- Jun 7, 2021
- Package NDCs
0487-6105-01- Official label
- DailyMed (National Library of Medicine), updated May 8, 2026
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