NDC 0143-9782
Fosphenytoin Sodium 50 mg per 1 mL injection, solution
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
- Apr 13, 2012 · Class II · West-ward Pharmaceutical Corp.
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Lots: Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, … - Apr 13, 2012 · Class II · West-ward Pharmaceutical Corp.
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Lots: Lot #s: a) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 10…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phenytoin: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA078765
- On the market since
- Dec 2, 2009
- Package NDCs
0143-9782-010143-9782-10- Official label
- DailyMed (National Library of Medicine), updated Jan 4, 2018
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