FDA-Drug2023-09-20Class II
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.
BE PHARMACEUTICALS AG
Hazard
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Sold states
Nationwide in the USA
Affected count
41,148 vials
Manufactured in
Bundesstrasse 3, Zug, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2023Don't want to check this manually?
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