Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in Ind...
FDA Recall #D-0340-2018 — Class I — December 4, 2017
Product Description
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Reason for Recall
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Recalling Firm
AuroMedics Pharma LLC — East Windsor, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
66,100 vials
Distribution
Product was distributed nationwide in the USA
Code Information
Lot # CPO170035
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated