Metoprolol Tartrate Tablet, Film Coated
FDA Recall NDC 65862-062
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 Metoprolol Tartrate (NDC 65862-062). A significant event, classified as Class II, was initiated on Sep 09, 2021 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet."
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
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Sep 09, 2021
Sep 29, 2021
2,820 bottles
Recall Profile & Regulatory Data
Event ID
88639
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 31, 2023
Product Description
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Batch or Lot Expiration Information
Lot# Lot: MJ1019025-A, Exp. date 04/2022
Affected Packages Involved in this Recall
65862-062-01Product
65862-062-99Product
65862-063-60Product
65862-063-01Product
65862-063-99Product
65862-064-60Product
65862-064-01Product
65862-064-99Product
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.
