ACE Inhibitor Recalled by Two Firms

A fragment of metal found embedded in a tablet has prompted Lupin Pharmaceuticals Inc and RemedyRepack, Inc to recall several lots of lisinopril, according to the September 21, 2022, US Food and Drug Administration (FDA) Enforcement Report.

Lupin Pharmaceuticals is recalling lisinopril tablets, 10 mg, 1000-count bottles (NDC 68180-980-03), manufactured for Lupin Pharmaceuticals Inc, Baltimore, MD, by Lupin Limited, Nagpur, India, from lot Q201182 (Exp. 3/24). The bottles were sent to major distributors and wholesalers throughout the United States.

RemedyRepack is recalling lisinopril tablets, 10 mg, 30-count blister cards, manufactured by Lupin Pharma, Baltimore, MD, repackaged by RemedyRepack, Inc, Indiana, PA (original NDC 68180-0980-03, repackaged NDC 70518-0468-00), from lots J0636336-073022 and J0637605-080422 (Exp. 8/31/23). The recalled blister cards were distributed to 2 direct accounts in Pennsylvania and Alaska.

Lupin Pharmaceuticals initiated its recall September 13, 2022, and RemedyRepack initiated its recall on September 15, 2022. On September 15, 2022, the FDA designated both recalls Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Lisinopril is a prescription medication used to treat high blood pressure and heart failure, and to reduce the risk of death after acute myocardial infarction.