Drug product
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
D-0340-2018
Product summary
- Event
- Event 78696
- Status
- Terminated
- Classification
- Class I
- Quantity
- 66,100 vials
- Official record key
drug-enforcement:D-0340-2018
Official wording
Reason: Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Code information: Lot # CPO170035
Distribution pattern: Product was distributed nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter