FDA recall D-0470-2017

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.

Distribution

Nationwide in US

Key facts

Status

Terminated

Initiation date

2016-12-16

Report date

2017-02-15

Termination date

2020-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2017