Rising Pharma Holding, Inc.: Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distr

Hazard

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Details from the source

Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Distribution: Nationwide. Quantity: 122,925 bottles Lot/code info: a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.