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
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Classification
Class II
Status
Terminated
Lot
a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25
Date
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