October 25, 2019
Dark brown discoloration on tablet edges has prompted Jubilant Cadista Pharmaceuticals Inc. to recall more than 60,000 bottles of pantoprazole sodium delayed-release tablets. The recall is included in the October 23, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 40-mg pantoprazole sodium delayed-release tablets packaged in 90-count bottles (NDC 59746-284-90) from two lots: PA218P008 and PA218P009 (Exp. 4/21). The tablets were sent to distributors in Mississippi, Ohio, Rhode Island, Tennessee, and Puerto Rico that may have forwarded the product to the retailers.
Jubilant Cadista Pharmaceuticals initiated the recall September 4, 2019. The FDA designated the recall Class II on October 17, 2019, communicating use of the tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Pantoprazole is a prescription proton-pump inhibitor used to treat gastroesophageal reflux disease, a damaged esophagus, and high levels of stomach acid.