NDC 71610-613
Metformin 500 mg tablet
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Granules Pharmaceuticals Inc.'s NDC 70010-491.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Granules Pharmaceuticals Inc. names for other drugs.
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Jul 3, 2020 · Class II · Granules Pharmaceuticals Inc
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
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, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA209313
- On the market since
- Jul 31, 2018
- Package NDCs
71610-613-3071610-613-5371610-613-6071610-613-7071610-613-8071610-613-94- Official label
- DailyMed (National Library of Medicine), updated Jun 10, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?