NDC 0143-9570
Sodium Ferric Gluconate Complex in Sucrose 12.5 mg per 1 mL injection
On the label: Hikma Pharmaceuticals USA Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hikma Farmaceutica (portugal), S.a | Terrugem Sintra, Portugal | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 21, 2023 · 9 inspections, 1 with FDA action |
Recalls
- Nov 17, 2016 · Class III · West-Ward Pharmaceuticals Corp.
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Lots: Lot #: 152032.1, Exp. Date. 2/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ferric Cation: every company that makes it
- Form
- injection, intravenous
- Strength
- 12.5 mg per 1 mL
- Approval
- ANDA ANDA078215
- On the market since
- Mar 31, 2011
- Package NDCs
0143-9570-010143-9570-10- Official label
- DailyMed (National Library of Medicine), updated Mar 21, 2025
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