Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 55111-468
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 Succinate (NDC 55111-468). A significant event, classified as Class II, was initiated on Apr 23, 2018 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets."
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 Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Apr 23, 2018
May 16, 2018
8160 bottles
Recall Profile & Regulatory Data
Event ID
79980
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 14, 2020
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
Batch or Lot Expiration Information
Batch# C706254, 08/2019
Affected Packages Involved in this Recall
55111-468-30Product
55111-468-60Product
55111-468-01Product
55111-468-05Product
55111-468-79Product
55111-468-78Product
55111-469-30Product
55111-469-60Product
55111-469-01Product
55111-469-05Product
55111-469-79Product
55111-469-78Product
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.
