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-0011-2019
Product summary
- Event
- Event 81162
- Status
- Terminated
- Classification
- Class II
- Quantity
- 158,466 bottles
- Official record key
drug-enforcement:D-0011-2019
Official wording
Reason: Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Code information: Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.
Distribution pattern: Product was distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Unknown
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.