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
Reported: November 27, 2024 Initiated: October 23, 2024 #D-0054-2025
Product 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
Reason for Recall
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 357,414 bottles
- Distribution
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 357,414 bottles.
Why was this product recalled? ▼
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2024. Severity: Moderate. Recall number: D-0054-2025.
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