Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 55111-466
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 55111-466). A significant event, classified as Class II, was initiated on May 23, 2014 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point."
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: Failure of dissolution test observed at the 18 month time point.
May 23, 2014
Jun 18, 2014
13560 bottles
Recall Profile & Regulatory Data
Event ID
68513
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 01, 2015
Product Description
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Batch or Lot Expiration Information
Lot# C206578 Exp. 05/2014
Lot# C207415 Exp. 06/2014
Affected Packages Involved in this Recall
55111-466-30Product
55111-466-60Product
55111-466-01Product
55111-466-05Product
55111-466-79Product
55111-466-78Product
55111-467-30Product
55111-467-60Product
55111-467-01Product
55111-467-05Product
55111-467-79Product
55111-467-78Product
December 2013 Class II Recall: Failed Dissolution Specification; 12-Month stability interval.
Recall Number
Class II Terminated
Failed Dissolution Specification; 12-Month stability interval.
Dec 13, 2013
Feb 12, 2014
8,592 bottles
Recall Profile & Regulatory Data
Event ID
67293
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
LA, MI, MO, MS & OH
Termination Date
Feb 12, 2015
Product Description
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01
Batch or Lot Expiration Information
Lot# C207420 and C207416
Affected Packages Involved in this Recall
55111-466-30Product
55111-466-60Product
55111-466-01Product
55111-466-05Product
55111-466-79Product
55111-466-78Product
55111-467-30Product
55111-467-60Product
55111-467-01Product
55111-467-05Product
55111-467-79Product
55111-467-78Product
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.
