Drug product
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
D-1381-2014
Product summary
- Event
- Event 68513
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13560 bottles
- Official record key
drug-enforcement:D-1381-2014
Official wording
Reason: Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Code information: Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications