Drug product
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90
D-1499-2016
Product summary
- Event
- Event 74949
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23016 bottles
- Official record key
drug-enforcement:D-1499-2016
Official wording
Reason: Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Code information: PSSB16011-A, Exp 01/18
Distribution pattern: CA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets