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Contaminant Prompts Recall of ACE Inhibitor

August 24, 2018

Following a report of a metal contaminant found in a tablet, Lupin Pharmaceuticals Inc. is pulling 11,706 bottles of 10-mg lisinopril tablets, USP. The recall appears in the August 22, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 1000-count bottles (NDC 68180-980-03) from lot H800414 (Exp. 12/19). The bottles were sent to distributors, mail-order pharmacies, and supermarkets throughout the United States.

Lupin Pharmaceuticals voluntarily initiated the recall August 13, 2018. The same day, the FDA designated the recall Class II. The classification signals use of the affected drug may cause temporary or medically reversible adverse health consequences, as well as a remote possibility of serious harm.

Lisinopril tablets are available with a prescription for the treatment of high blood pressure, congestive heart failure, and heart attack.

Jolynn Tumolo

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