Recall D-0053-2025

US Class II Terminated · initiated 2024-10-23

Recalling firm

Lupin Pharmaceuticals Inc., MD

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

Reason for recall

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

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