NDC 71455-104
Metformin Hydrochloride 500 mg tablet, film coated
On the label: Unyter Enterprises. It's repackaged: Unyter Enterprises rebottles it from Aurobindo Pharma Limited's NDC 65862-008.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- UNYTER Enterprises, Cumming, GA, United States · repackages it and relabels it
Recalls
- Feb 2, 2018 · Class III · Aurobindo Pharma Ltd.
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Lots: Lot#: MTSC17145-A, Exp. July 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, film coated
- Strength
- 500 mg
- Approval
- ANDA ANDA077095
- On the market since
- Jan 27, 2011
- Package NDCs
71455-104-00- Official label
- DailyMed (National Library of Medicine), updated Jul 13, 2020
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