Drug product
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
D-1080-2014
Product summary
- Event
- Event 67293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,592 bottles
- Official record key
drug-enforcement:D-1080-2014
Official wording
Reason: Failed Dissolution Specification; 12-Month stability interval.
Code information: Lot # C207420 and C207416
Distribution pattern: LA, MI, MO, MS & OH
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification