Drug product
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
D-296-2013
Product summary
- Event
- Event 64869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12770 bottles
- Official record key
drug-enforcement:D-296-2013
Official wording
Reason: cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Code information: Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations