Lupin Pharmaceuticals Inc. — 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
⚠️ 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 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
- Brand
- RAMIPRIL
- UPC
- 0368180591092
- Lot code
- G326781
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 112,770 bottles.
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