Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 72578-035
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 (NDC 72578-035). A significant event, classified as Class II, was initiated on Dec 27, 2021 by Viona Pharmaceuticals Inc. The reported reason for this action was: "CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
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
December 2021 Class II Recall: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall Number
Class II Terminated
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Dec 27, 2021
Feb 02, 2022
23,8416/100 count bottles
Recall Profile & Regulatory Data
Event ID
89305
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Termination Date
Sep 20, 2023
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Batch or Lot Expiration Information
Lot# M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
Affected Packages Involved in this Recall
72578-035-01Product
72578-035-05Product
72578-036-01Product
72578-036-05Product
Class II Terminated
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Jun 01, 2021
Jun 30, 2021
21240 bottles
Recall Profile & Regulatory Data
Event ID
88033
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
May 31, 2023
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Batch or Lot Expiration Information
Lot# Lot M915601 & M915602, Oct 2021
Affected Packages Involved in this Recall
72578-035-01Product
72578-035-05Product
72578-036-01Product
72578-036-05Product
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.
