Drug product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
D-1074-2019
Product summary
- Event
- Event 82523
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,960 bottles
- Official record key
drug-enforcement:D-1074-2019
Official wording
Reason: Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Code information: Lot #: PA217060A, Exp 05/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.