NDC 53149-4840
Chlorhexidine Gluconate 1.2 mg per 1 mL rinse
On the label: All Pharma, LLC. It's repackaged: All Pharma, LLC rebottles it from Xttrium Laboratories, Inc.'s NDC 0116-2001.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Xttrium Laboratories, Inc. | Mount Prospect, IL, United States | Makes it | Problems found, fixed voluntarilyJun 16, 2026 · 17 inspections, 2 with FDA action |
Repackaging site
- All Pharma, LLC, Miami Lakes, Florida, United States · makes it and repackages it
Recalls
- Jun 1, 2017 · Class II · Xttrium Laboratories Inc
CGMP Deviations
Lots: 1999CHG16MC-Lot number 704-201 (full lot # 704-1999-201), Exp 03/20 1999CHG16MC-Lot number 705-208 (full lot # 705-1999-208), Exp 04/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Chlorhexidine: every company that makes it
- Form
- rinse
- Strength
- 1.2 mg per 1 mL
- Approval
- ANDA ANDA077789
- On the market since
- Jun 1, 2010
- Package NDCs
53149-4840-1- Official label
- DailyMed (National Library of Medicine), updated Dec 22, 2017
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