NDC 16590-397
Metformin Hydrochloride 1000 mg tablet, film coated
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-030.
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 Zydus Pharmaceuticals (USA) Inc. names for other drugs.
Repackaging site
- Stat Rx USA, Location not on file · repackages it and relabels it
Recalls
- Mar 14, 2012 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Lots: Lot #: ML9605 Exp. 10/2013
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
- 1000 mg
- Approval
- ANDA ANDA077064
- On the market since
- Sep 28, 2005
- Package NDCs
16590-397-3016590-397-6016590-397-90- Official label
- DailyMed (National Library of Medicine), updated Oct 4, 2012
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?