Recall: D-1148-2023

Class II - Potentially Harmful

Class IIClassification

2023-09-05Initiated

TerminatedStatus

BE PHARMACEUTICALS AGFirm

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.

Reason

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.