Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufa...
FDA Recall #D-1720-2019 — Class II — July 17, 2019
Product Description
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
Reason for Recall
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
39,216 bottles
Distribution
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Code Information
Batch# H900575, exp. date 01/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated