Recall Enforment Report D-1502-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 04-06-2016 for the product Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA. The product was recalled due to cgmp deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.. The product was distributed in All Product Distributed Domestically In The Us. No Recalled Product Was Distributed To U.s. Government Agency Consignees Directly By Lupin. No Recalled Product Was Distributed To Any Foreign Consignees By Lupin. and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1502-201604-06-201609-28-2016Class III20,556 bottlesLisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.Terminated
D-1503-201604-06-201609-28-2016Class III5,880 bottlesLisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-512Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-513Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-514Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-515Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-516Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-517Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-979Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-980Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-981Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug
68180-982Lisinopril LisinoprilTabletOralLupin Pharmaceuticals, Inc.Human Prescription Drug