February 20, 2017
Aurobindo Pharma USA Inc is voluntarily recalling of 29,800 single-dose vials of Pantoprazole Sodium for Injection, 40 mg per vial.
The ongoing Class III recall was initiated on account of discoloration.
“Some vials were found to contain powder with a yellowish-brownish appearance,” the US Food and Drug Administration (FDA) stated in its latest Enforcement Report.
The impacted vials are from lot number CPO160028 (Exp. June 2018). They were distributed throughout the United States.
The FDA gave the recall, which was initiated by Aurobindo Pharma USA on December 16, 2016, a Class III classification on February 8, 2017.
Pantoprazole Sodium for Injection is used for the treatment of individuals with gastroesophageal reflux disease and a history of erosive esophagitis and for the treatment of those with pathological hypersecretory conditions.--Meredith Edwards White