December 2016 FDA Recall Pantoprazole Sodium by Aurobindo Pharma Usa Inc
D-0470-2017 - Discoloration
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc on December 16, 2016 for the product Pantoprazole Sodium. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0470-2017
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
12-16-2016
02-15-2017
29800 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in US
07-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : CPO160028, Exp. June 2018
