Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin P…

Recall date

July 17, 2019

Source

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

Recall number

D-1720-2019

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.

Why it was recalled

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01