FDAHealthOctober 23, 2024
Lupin Pharmaceuticals Inc. — 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 Ph
⚠️ 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 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
- Brand
- RAMIPRIL
- UPC
- 0368180591092
- Lot code
- G326928
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 146,322 bottles.
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