Recalls / Class II
Class IID-1148-2023
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.
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Intravenous
- NDC
- 71839-122
- FDA application
- ANDA216171
- Affected lot / 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;
Why it was recalled
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Recalling firm
- Firm
- BE PHARMACEUTICALS AG
- Manufacturer
- BE Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Bundesstrasse 3, Zug, N/A, Switzerland
Distribution
- Quantity
- 41,148 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-05
- FDA classified
- 2023-09-11
- Posted by FDA
- 2023-09-20
- Terminated
- 2025-04-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1148-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.