NDC 43386-060
GaviLyte - CTM 5 ingredients powder, for solution
On the label: Lupin Pharmaceuticals, 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
- Apr 27, 2022 · Class II · Lupin Pharmaceuticals Inc.
Failed Stability Specification
Lots: Lot # S001132, exp. date July 2022 NDC # 43386-060-19 - Jul 29, 2021 · Class II · Novel Laboratories, Inc. d.b.a LUPIN
Failed Stability Specification; Out of specification for Osmolarity
Lots: Lot S001133, exp 7/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Polyethylene Glycol-3350 and Electrolytes: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 5 ingredients
- Approval
- ANDA ANDA090186
- On the market since
- Jan 6, 2009
- Package NDCs
43386-060-19- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2025
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