Recall: D-0470-2017

Class III - Minor Violations

Class IIIClassification

2016-12-16Initiated

TerminatedStatus

Aurobindo Pharma USA IncFirm

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

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

Distribution

Nationwide in US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.