Drug product
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
D-0470-2017
Product summary
- Event
- Event 75997
- Status
- Terminated
- Classification
- Class III
- Quantity
- 29800 vials
- Official record key
drug-enforcement:D-0470-2017
Official wording
Reason: Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Code information: Lot #: CPO160028, Exp. June 2018
Distribution pattern: Nationwide in US
Derived failure modes
-
Unknown
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.