Status
Terminated
Drug Enforcement D-1148-2023
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Classification
Class II
Report Date
September 20, 2023
Termination Date
April 8, 2025
Product Information
- Product description
- 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.
- Product quantity
- 41,148 vials
- Reason for recall
- Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- BE PHARMACEUTICALS AG
- Address
-
Bundesstrasse 3
Switzerland - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1148-2023
- Event ID
- 92968
- Recall initiation date
- September 5, 2023
- Center classification date
- September 11, 2023
- Code info
- Lots: (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; GSC10003A, GSC10005A Exp Sep-2024;GSC06004A, GSC06005A, Exp May-2024; GSC07001A, GSC07007A, GSC07008A, GSC07009A, Exp Jun-2024; GSC08001A, Exp Jul-2024; GSC05009A, Exp Apr-2024; (b) GSC04005A, Exp Mar-2024; GSC06003A, Exp May-2024; GSC10001A, Exp Sep-2024; GSC07006A,Exp Jun-2024; GSC08002A, Exp Jul-2024; GSD02012A, Exp Jan-2025; GSD03005A, GSD03008A, Exp Feb-2025;
- More code info
- —