Metformin Hydrochloride Extended Release Tablet, Extended Release
FDA Recall NDC 49483-623

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

Active & Historical Enforcement Reports

The FDA has identified 3 recorded enforcement report(s) associated with Metformin Hydrochloride Extended Release (NDC 49483-623). A significant event, classified as Class II, was initiated on Oct 02, 2020 by Time Cap Laboratories, Inc. The reported reason for this action was: "CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level"

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-0062-2021TERMINATEDD-0061-2021TERMINATEDD-1356-2020TERMINATED

October 2020 Class II Recall: CGMP Deviations

Recall Number
D-0062-2021
Class II Terminated
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
Oct 02, 2020
Reported
Nov 11, 2020
Quantity
368,976 bottles

Recall Profile & Regulatory Data

Event ID
86530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Marksans Pharma Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 21, 2024
Product Description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
49483-623-09Product
49483-623-01Product
49483-623-50Product
49483-623-10Product
49483-624-01Product
49483-624-50Product

October 2020 Class II Recall: CGMP Deviations

Recall Number
D-0061-2021
Class II Terminated
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
Oct 02, 2020
Reported
Nov 11, 2020
Quantity
a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles

Recall Profile & Regulatory Data

Event ID
86530
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Marksans Pharma Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 21, 2024
Product Description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
Batch or Lot Expiration Information
Lot# 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) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22
Affected Packages Involved in this Recall
49483-623-09Product
49483-623-01Product
49483-623-50Product
49483-623-10Product
49483-624-01Product
49483-624-50Product

June 2020 Class II Recall: CGMP Deviations

Recall Number
D-1356-2020
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
11279 bottles

Recall Profile & Regulatory Data

Event ID
85818
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Marksans Pharma Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 07, 2023
Product Description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Batch or Lot Expiration Information
Lot# XP9004, exp 12/2020
Affected Packages Involved in this Recall
49483-623-09Product
49483-623-01Product
49483-623-50Product
49483-623-10Product
49483-624-01Product
49483-624-50Product

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.