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.
Reported: September 20, 2023 Initiated: September 5, 2023 #D-1148-2023
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.
Reason for Recall
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Details
- Recalling Firm
- BE PHARMACEUTICALS AG
- Units Affected
- 41,148 vials
- Distribution
- Nationwide in the USA
- Location
- Zug
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BE PHARMACEUTICALS AG. Units affected: 41,148 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 20, 2023. Severity: Moderate. Recall number: D-1148-2023.
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