NDC 71610-447

Metformin Hydrochloride 500 mg tablet, extended release

On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Sun Pharmaceutical Industries, Inc.'s NDC 62756-142.

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 Sun Pharmaceutical Industries, Inc. names for other drugs.

Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it

May 4, 2021 · Class II · Sun Pharmaceutical Industries Inc
Presence of foreign substance: identified as activated carbon.
Lots: Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.
Mar 25, 2021 · Class III · Sun Pharmaceutical Industries Inc
Failed Moisture Limits: Out of specification for water content
Lots: Lot #JKU4639A, Exp 10/2022
Jul 3, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Lots: Lot #: JKT0042A, Exp 1/2021
Jan 28, 2014 · Class II · Caraco Pharmaceutical Laboratories, Ltd.
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Lots: Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Metformin: every company that makes it
Form: tablet, extended release, oral
Strength: 500 mg
Approval: ANDA ANDA077336
On the market since: Feb 9, 2006
Package NDCs: 71610-447-30 71610-447-53 71610-447-60 71610-447-70 71610-447-80 71610-447-94
Official label: DailyMed (National Library of Medicine), updated Apr 27, 2021

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