FDA-Drug2016-07-06Class III
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Sold states
Nationwide and Puerto Rico
Affected count
59,520 Bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1052-2016More Lupin Pharmaceuticals Inc. recalls
- FDA-Drug2026-07-08Lupin Pharmaceuticals prednisolone acetate eye drops recalled for foreign substance contamination
- FDA-Drug2026-07-08Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
- FDA-Drug2026-05-27Lupin Liraglutide Injection recalled for particulate matter in cartridges
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