Status
Ongoing
Drug Enforcement D-0052-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Classification
Class II
Report Date
November 27, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 112,770 bottles
- Reason for recall
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Location & Firm
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address
-
Harborplace Tower, 111 S Calvert St Fl 21st
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0052-2025
- Event ID
- 95610
- Recall initiation date
- October 23, 2024
- Center classification date
- November 19, 2024
- Code info
- 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
- More code info
- —