Status
Ongoing
Drug Enforcement D-0053-2025
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 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
- Product quantity
- 146,322 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-0053-2025
- Event ID
- 95610
- Recall initiation date
- October 23, 2024
- Center classification date
- November 19, 2024
- Code info
- 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
- More code info
- —