Drug recall D-0470-2017

Class III Terminated reported Feb 15, 2017

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

Reason for recall

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

Lots and codes

Lot #: CPO160028, Exp. June 2018

Recall details

Recalling firm
Aurobindo Pharma USA Inc, Plainsboro, NJ
Quantity
29800 vials
Distribution
Nationwide in US
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2016
Terminated
July 29, 2020

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