RAMIPRIL Recall D-0054-2025
Description: Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
RAMIPRIL Recall D-0054-2025 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0054-2025 |
Event ID | 95610 |
Brand | RAMIPRIL |
Generic Name | RAMIPRIL |
Manufacturer | RAMIPRIL |
Original Package? | 1 |
Active Substance | RAMIPRIL |
Drug Route | ORAL |
Distribution | Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. |
Quantity | 357,414 bottles |
Recall Reason | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor |
Drug Classification | Class II |
Drug Code Info | 20241127 |
Product NDC | 68180-588 68180-589 68180-590 |
Product NUI | N0000175562 N0000000181 |
Drug UPC | 0368180589099 0368180590095 0368180591092 |
Pharma Class (EPC) | Angiotensin Converting Enzyme Inhibitor [EPC] |
Recall Initiation Date | 20241023 |
Report Date | 20241127 |
Classification Date | 20241119 |
Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
Recalling Firm | Lupin Pharmaceuticals Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | L35JN3I7SJ |
Drug Application Number | ANDA077626 |
Structured Product Labeling (SPL ID) | 25692bd2-4add-49c4-adad-baed736213c6 |
Structured Product Labeling (SPL Set ID) | a8cdec12-81d1-4ef4-82c0-d05d93c37a07 |
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