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Recall Observatory FDA recall evidence

Drug product

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 Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

D-0052-2025

October 23, 2024

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 95610
Status
Terminated
Classification
Class II
Quantity
112,770 bottles
Official record key
drug-enforcement:D-0052-2025

Official wording

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

Code information: 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

Distribution pattern: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations