Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 72189-150
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 72189-150). A significant event, classified as Class II, was initiated on Oct 12, 2020 by Direct Rx. 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.
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
Class II Terminated
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Oct 12, 2020
Nov 11, 2020
88 bottles
Recall Profile & Regulatory Data
Event ID
86601
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Direct Rx
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL
Termination Date
Sep 22, 2021
Product Description
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Batch or Lot Expiration Information
Lot# Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
Affected Packages Involved in this Recall
72189-150-90Product
72189-150-30Product
72189-064-90Product
72189-064-30Product
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.
