Lupin Pharmaceuticals Inc. recalls Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx
Recalled July 6, 2016 · FDA recall D-1052-2016 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. · FDA Class III
Units
59,520 Bottles
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →