Metoprolol Tartrate Tablet, Film Coated
FDA Recall NDC 52817-362
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 Metoprolol Tartrate (NDC 52817-362). A significant event, classified as Class II, was initiated on May 06, 2024 by Trupharma Llc. The reported reason for this action was: "Presence of Foreign Substance: metal in tablet"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Foreign Substance: metal in tablet
May 06, 2024
Jun 05, 2024
11,664 Bottles
Recall Profile & Regulatory Data
Event ID
94542
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rubicon Research Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Batch or Lot Expiration Information
Lot# Lot 231037H1, exp 6/2027
Affected Packages Involved in this Recall
52817-362-10Product
52817-362-00Product
52817-359-10Product
52817-359-50Product
52817-361-10Product
52817-361-00Product
52817-360-10Product
52817-360-00Product
52817-358-10Product
52817-358-50Product
December 2021 Class II Recall: Complaint received of foreign matter (metal) embedded in tablet.
Recall Number
Class II Terminated
Complaint received of foreign matter (metal) embedded in tablet.
Dec 31, 2021
Jan 19, 2022
3,684 1000-count bottles
Recall Profile & Regulatory Data
Event ID
89311
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Rubicon Research Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one distributor who may have distributed the product further nationwide.
Termination Date
Nov 04, 2022
Product Description
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Batch or Lot Expiration Information
Batch# 210211H1, Exp. date FEB 2024
Affected Packages Involved in this Recall
52817-362-10Product
52817-362-00Product
52817-359-10Product
52817-359-50Product
52817-361-10Product
52817-361-00Product
52817-360-10Product
52817-360-00Product
52817-358-10Product
52817-358-50Product
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.
