Metformin Hydrochloride Extended Release Tablet, Extended Release
FDA Recall NDC 72789-009

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Metformin Hydrochloride Extended Release (NDC 72789-009). A significant event, classified as Class II, was initiated on Oct 06, 2020 by Pd-rx Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0059-2021TERMINATEDD-1333-2020TERMINATED

October 2020 Class II Recall: CGMP Deviations

Recall Number
D-0059-2021
Class II Terminated
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Initiated
Oct 06, 2020
Reported
Nov 11, 2020
Quantity
1683 bottles

Recall Profile & Regulatory Data

Event ID
86600
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Termination Date
Oct 22, 2021
Product Description
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Batch or Lot Expiration Information
Lot# 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) B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22
Affected Packages Involved in this Recall
72789-009-30Product
72789-009-60Product
72789-009-90Product
72789-009-93Product

June 2020 Class II Recall: CGMP Deviations

Recall Number
D-1333-2020
Class II Terminated
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
Jun 05, 2020
Reported
Jul 01, 2020
Quantity
1969 bottles

Recall Profile & Regulatory Data

Event ID
85828
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States.
Termination Date
Nov 08, 2021
Product Description
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
Batch or Lot Expiration Information
Lot# 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. 12/31/2020; e) XP9004 Exp. 12/31/2020
Affected Packages Involved in this Recall
72789-009-30Product
72789-009-60Product
72789-009-90Product
72789-009-93Product
49483-0623-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.