NDC 61919-395
Eszopiclone 3 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Macleods Pharmaceuticals Limited's NDC 33342-301.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | District Solan, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 20, 2023 · 6 inspections, 2 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jun 16, 2022 · Class II · Macleods Pharma Usa Inc
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Lots: Lot #: BEK2009A Exp: 11/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Eszopiclone: every company that makes it
- Form
- tablet, film coated
- Strength
- 3 mg
- Approval
- ANDA ANDA202929
- On the market since
- Mar 12, 2018
- Package NDCs
61919-395-30- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2023
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?