FDA recall D-1720-2019

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 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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-17

Report date

2019-08-21

Termination date

2020-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1720-2019