NDC 29033-055
Metformin Hydrochloride 500 mg tablet, extended release
On the label: Nostrum Laboratories, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nostrum Laboratories, Inc. | Bryan, Ohio, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 13, 2025 · 6 inspections |
Recalls
- Oct 23, 2020 · Class II · Nostrum Laboratories Inc
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: MET100201, MET100401 EXP 05/2022
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
- Strength
- 500 mg
- Approval
- ANDA ANDA076756
- On the market since
- Aug 6, 2020
- Package NDCs
29033-055-0129033-055-0529033-055-10- Official label
- DailyMed (National Library of Medicine), updated Nov 26, 2024
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