Drug Recall: 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., Baltimor
Lupin Pharmaceuticals Inc. · October 23, 2024
Reason for Recall
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
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
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
States Affected
NATIONWIDE
Quantity Affected
146,322 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0053-2025
Status: terminated
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