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FDAFDA · Food and drugs·Recall number D-0052-2025

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

Published November 27, 2024 · Recall initiated: October 23, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
RAMIPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Distributor
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
UPC
0368180591092
Lot
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
Risk classification
Class II
Area (FDA)
drug
Country
United States

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