NDC 72578-036
Metformin Hydrochloride 750 mg tablet, extended release
On the label: Viona Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- Dec 27, 2021 · Class II · Viona Pharmaceuticals Inc
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lots: M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/… - Jun 1, 2021 · Class II · Viona Pharmaceuticals Inc
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lots: Lot M915601 & M915602, Oct 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
- 750 mg
- Approval
- ANDA ANDA077078
- On the market since
- Mar 15, 2019
- Package NDCs
72578-036-0172578-036-05- Official label
- DailyMed (National Library of Medicine), updated Jun 26, 2026
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