Aurobindo Pharma USA Inc recalls Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6…

Recall date

December 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0470-2017

FDA classification

Class III

Brand / firm

Aurobindo Pharma USA Inc

Sold / distributed

Nationwide in US

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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