NDC 70518-4369
Metformin Hydrochloride 1000 mg tablet, extended release
On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-337.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Recalls
- Jul 7, 2020 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 1000 mg
- Approval
- ANDA ANDA090692
- On the market since
- Jun 24, 2025
- Package NDCs
70518-4369-070518-4369-170518-4369-2- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2026
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