FDA recall D-1581-2019

Product

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02

Reason for recall

Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-07-19

Report date

2019-07-31

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1581-2019