Drug product
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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-0145-2020
Product summary
- Event
- Event 83705
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63,216 bottles
- Official record key
drug-enforcement:D-0145-2020
Official wording
Reason: CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Code information: Lot # PA218P008, PA218P009, Exp 04/2021
Distribution pattern: Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
Derived failure modes
-
Manufacturing or process control
CGMP Deviation