NDC 61919-913
Metoprolol Succinatee/R 50 mg tablet, extended release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-467.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- May 23, 2014 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Lots: Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014 - Dec 13, 2013 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specification; 12-Month stability interval.
Lots: Lot # C207420 and C207416
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metoprolol: every company that makes it
- Form
- tablet, extended release
- Strength
- 50 mg
- Approval
- ANDA ANDA090617
- On the market since
- Nov 10, 2017
- Package NDCs
61919-913-30- Official label
- DailyMed (National Library of Medicine), updated Nov 10, 2017
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