Recall: D-1720-2019

Class II - Potentially Harmful

Class IIClassification

2019-07-17Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

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

Distribution

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.