Lupin Pharmaceuticals Inc.: Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Ph

Hazard

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Details from the source

Reason for recall: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Distribution: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. Quantity: 357,414 bottles Lot/code info: a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25

Source

Official record: FDA (Drug enforcement) ↗

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