Drug 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
D-0053-2025
Product summary
- Event
- Event 95610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146,322 bottles
- Official record key
drug-enforcement:D-0053-2025
Official wording
Reason: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Code information: 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
Distribution pattern: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations