Lisinopril & Hydrochlorothiazide Tables recalled over manufacturing violations

Recall date

April 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Lupin Pharmaceuticals Inc. recalls Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx…

Recall number

D-1052-2016

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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