NDC 72789-009

Metformin Hydrochloride Extended Release 500 mg tablet, extended release

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

Where the pills inside were made

Repackaging site

• PD-Rx Pharmaceuticals Inc., Oklahoma City, OK, United States · repackages it

Recalls

• Oct 6, 2020 · Class II · PD-Rx Pharmaceuticals, Inc.
  CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
  Lots: Lots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22; c) A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22; d) B20…
• 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
• Jun 5, 2020 · Class II · PD-Rx Pharmaceuticals, Inc.
  CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
  Lots: Lots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020; c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020; d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. …

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, oral

Strength

500 mg

Approval

ANDA ANDA090295

On the market since

May 12, 2016

Package NDCs

72789-009-30 72789-009-60 72789-009-90 72789-009-93

Official label

DailyMed (National Library of Medicine), updated Jul 7, 2026

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