NDC 72189-150
Metformin Hydrochloride 500 mg tablet, extended release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from TAGI Pharma, Inc.'s NDC 51224-007.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | Shijiazhuang, China | Makes it, tests it and packages it | Problems found, fixed voluntarilySep 5, 2024 · 8 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Oct 12, 2020 · Class II · Direct Rx
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Lots: Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA078321
- On the market since
- Oct 14, 2020
- Package NDCs
72189-150-3072189-150-90- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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