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Recall Observatory FDA recall evidence

Drug product

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

D-0053-2025

October 23, 2024

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 95610
Status
Terminated
Classification
Class II
Quantity
146,322 bottles
Official record key
drug-enforcement:D-0053-2025

Official wording

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

Code information: a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25

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