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Recall Enforment Report D-0053-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 10-23-2024 for the 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 The product was recalled due to cgmp deviations: active pharmaceutical ingredient was sourced from an unapproved vendor. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0053-202510-23-202411-27-2024Class II146,322 bottlesRamipril 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, IndiaCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendorOngoing
D-0054-202510-23-202411-27-2024Class II357,414 bottlesRamipril 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 Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, IndiaCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendorOngoing
D-0052-202510-23-202411-27-2024Class II112,770 bottlesRamipril 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, IndiaCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendorOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-588Ramipril RamiprilCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-589Ramipril RamiprilCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-590Ramipril RamiprilCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-591Ramipril RamiprilCapsuleOralLupin Pharmaceuticals, Inc.Human Prescription Drug