Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 68001-503
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 Succinate (NDC 68001-503). A significant event, classified as Class II, was initiated on Jan 11, 2023 by Bluepoint Laboratories. The reported reason for this action was: "Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories."
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
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Jan 11, 2023
Feb 22, 2023
(a) 6670 100-count (b) 2666 500-count bottles
Recall Profile & Regulatory Data
Event ID
91528
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
May 12, 2024
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
Batch or Lot Expiration Information
Lot# Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Affected Packages Involved in this Recall
68001-500-00Product
68001-500-03Product
68001-500-08Product
68001-501-00Product
68001-501-03Product
68001-501-08Product
68001-502-00Product
68001-502-03Product
68001-502-08Product
68001-503-00Product
Class II Terminated
Failed Dissolution Specifications
Dec 20, 2021
Feb 02, 2022
6,637 500-count bottles
Recall Profile & Regulatory Data
Event ID
89377
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 09, 2023
Product Description
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
Batch or Lot Expiration Information
Lot# Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023
Affected Packages Involved in this Recall
68001-500-00Product
68001-500-03Product
68001-500-08Product
68001-501-00Product
68001-501-03Product
68001-501-08Product
68001-502-00Product
68001-502-03Product
68001-502-08Product
68001-503-00Product
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.
