FDA Recall Metoprolol Succinate
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Metoprolol Succinate with NDC 55111-466 was initiated on 05-23-2014 as a Class II recall due to failed dissolution specifications: failure of dissolution test observed at the 18 month time point. The latest recall number for this product is D-1381-2014 and the recall is currently terminated as of 05-01-2015 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1381-2014 | 05-23-2014 | 06-18-2014 | Class II | 13560 bottles | 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 | Terminated |
| D-1080-2014 | 12-13-2013 | 02-12-2014 | Class II | 8,592 bottles | 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 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.