Lupin Pharmaceuticals Issues Recall for Blood Pressure Meds
The FDA announced that Lupin Pharmaceuticals has pulled a lot of its lisinopril 20mg and hydrochlorothiazide 12.5mg tablets, following a complaint regarding a foreign drug tablet.
The agency, which posted the recall of the to its Enforcement Report database, said that a customer discovered a 145mg fenofibrate tablet — used to lower high cholesterol and triglyceride levels — in a 500 count product bottle.
The lot was manufactured at Lupin’s Pithampur, Madhya Pradesh facility, which was hit with a Form 483 following a December 2018 inspection. The investigator noted subpar written procedures for cleaning and maintenance and data integrity concerns.