Product: Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
Reason for recall: Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Recall initiated: 20230905
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated