Lupin Pharmaceuticals Inc.: Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin P

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: 112,770 bottles Lot/code info: a) NDC 68180-589-09; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC 68180-589-01; Lots G326763, exp. date 30-Sep-25, GA03041, exp. date 31-Mar-26, GA03725, exp. date 30-Apr-26, GA04402, exp. date 31-May-26, c) NDC 68180-589-02; Lots G326782, exp. date 30-Sep-25, GA04462, exp. date 31-May-26

Source

Official record: FDA (Drug enforcement) ↗

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