Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical

Hazard

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

Details from the source

Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Distribution: Nationwide within the United States Quantity: 359,676 bottles Lot/code info: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.

Source

Official record: FDA (Drug enforcement) ↗

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