NDC 61919-202
Amoxicillin And Clavulanate Potassium 125 mg / 875 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-503.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Serious problems, FDA actionSep 5, 2025 · 8 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Feb 7, 2020 · Class II · AuroMedics Pharma LLC
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Lots: Lot #: SM8719040-A, Exp. Date 02/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amoxicillin and Clavulanic Acid: every company that makes it
- Form
- tablet, film coated
- Strength
- 125 mg / 875 mg
- Approval
- ANDA ANDA091568
- On the market since
- Jan 1, 2015
- Package NDCs
61919-202-20- Official label
- DailyMed (National Library of Medicine), updated Nov 12, 2015
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