FDA-Drug2024-11-27Class II
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
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Sold states
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Affected count
357,414 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2025Don't want to check this manually?
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