GERD Injection Recalled

Methapharm Inc is recalling 5377 cartons of pantoprazole sodium injections due to deviations from Current Good Manufacturing Practices. According to the May 3, 2023, US Food and Drug Administration (FDA) Enforcement Report, “The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.” No further details were provided.

The recall affects pantoprazole sodium for injection, 40 mg, single-dose vial (vial NDC 67850-150-00, carton NDC 67850-150-10), from lots 220801, 220802, and 220803 (Exp 7/24). The product was manufactured for Methapharm Inc, Coral Springs, Florida, and distributed throughout the United States.

Methapharm voluntarily initiated the recall April 7, 2023. On April 21, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

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.