NDC 0093-3560
Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid 6 ingredients kit
On the label: Teva Pharmaceuticals USA, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Recalls
- Jul 2, 2024 · Class III · Novel Laboratories, Inc. d.b.a Lupin Somerset
Defective container: potential for non-sealed pouches which can lead to product leakage.
Lots: Lot #S300542, exp. date June 30, 2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate : every company that makes it
- Form
- kit
- Strength
- 6 ingredients
- Approval
- ANDA ANDA090145
- On the market since
- Aug 31, 2020
- Package NDCs
0093-3560-190093-3560-260093-9043-190093-9044-19- Official label
- DailyMed (National Library of Medicine), updated Apr 14, 2022
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