Drug product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
D-1058-2020
Product summary
- Event
- Event 85181
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,376 90-count bottles
- Official record key
drug-enforcement:D-1058-2020
Official wording
Reason: CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Code information: Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations