Drug product
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
D-0841-2016
Product summary
- Event
- Event 73822
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,280 bottles
- Official record key
drug-enforcement:D-0841-2016
Official wording
Reason: Failed Impurities/Degradation Specifications; 12 month stability time point
Code information: Lot number C500691, exp 12/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications