NDC 72189-107
Levothyroxine Sodium 0.075 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-967.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Dec 20, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lots: Lot# LA01276, Exp Date: 07/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levothyroxine: every company that makes it
- Form
- tablet, oral
- Strength
- 0.075 mg
- Approval
- ANDA ANDA209713
- On the market since
- May 18, 2020
- Package NDCs
72189-107-3072189-107-90- Official label
- DailyMed (National Library of Medicine), updated May 23, 2024
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