Drug product
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
D-059-2013
Product summary
- Event
- Event 63524
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1512 bottles
- Official record key
drug-enforcement:D-059-2013
Official wording
Reason: Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Code information: Lot C203090 Exp.03/14
Distribution pattern: Nationwide. No foreign consignees.
Derived failure modes
-
Unknown
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.