Why it was recalled
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
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.
Lot numbers, UPCs & expiration codes
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;
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1148-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2023
- FDA report date
- Sep 20, 2023
- Quantity
- 41,148 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BE PHARMACEUTICALS AG
Original FDA data
Every field from FDA enforcement report D-1148-2023, exactly as published.
Show all FDA fields
- City
- Zug
- Status
- Terminated
- Country
- Switzerland
- Event ID
- 92968
- Address
- Bundesstrasse 3
- Code information
- 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;
- Report date
- Sep 20, 2023
- Product type
- Drugs
- Recall number
- D-1148-2023
- Classification
- Class II
- Recalling firm
- BE PHARMACEUTICALS AG
- Product quantity
- 41,148 vials
- Termination date
- Apr 8, 2025
- Reason for recall
- Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 5, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2023