Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for:...
FDA Recall #D-0470-2017 — Class III — December 16, 2016
Product Description
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Reason for Recall
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Recalling Firm
Aurobindo Pharma USA Inc — Plainsboro, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
29800 vials
Distribution
Nationwide in US
Code Information
Lot #: CPO160028, Exp. June 2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated