Recall
FDAHealthOctober 23, 2024

Lupin Pharmaceuticals Inc. — Ramipril 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 P

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 23, 2024

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

What's affected?

Product
Ramipril 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, India
UPC
0368180591092
Lot code
G327086

Additional details

a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 357,414 bottles.

View original FDA notice →

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