NDC 53002-1500

Metformin Hydrochloride Extended Release 500 mg tablet, extended release

On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Time Cap Laboratories's NDC 49483-623.

Where the pills inside were made

Repackaging site

• RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it

Recalls

• Oct 2, 2020 · Class II · Marksans Pharma Limited
  CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
  Lots: a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) …
• Oct 2, 2020 · Class II · Marksans Pharma Limited
  CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
  Lots: M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
• Jun 5, 2020 · Class II · Marksans Pharma Limited
  CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
  Lots: XP9004, exp 12/2020

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

Strength

500 mg

Approval

ANDA ANDA090295

On the market since

May 12, 2016

Package NDCs

53002-1500-0 53002-1500-3

Official label

DailyMed (National Library of Medicine), updated Oct 23, 2023

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