February 19, 2021
Sun Pharmaceutical Industries Inc. is recalling 20,475 vials of pantoprazole sodium for injection because samples failed to meet impurity/degradation specifications during testing, according to the February 17, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects pantoprazole sodium for injection, 40 mg/vial, for intravenous infusion only (NDC 62756-129-40), from lots JKU3595A, JKU3596A, JKU3597A, and JKU3629A (Exp. 2/21). The affected vials were distributed throughout the United States.
Sun Pharmaceutical Industries voluntarily initiated the recall February 5, 2021. On February 9, 2021, the FDA designated the recall Class III, suggesting use of recalled products is not likely to cause harm.
Pantoprazole sodium injection is a prescription proton pump inhibitor used for the short-term treatment of adults with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. It is also indicated for the treatment of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions in adults.