Losartan 50mg Tablet recalled over manufacturing violations

Recall date

March 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RemedyRepack Inc. recalls Losartan 50mg Tablet, 30 count each blister card.

Recall number

D-1081-2019

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

Product was distributed to one sole customer, Miami, FL.

Why it was recalled

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Losartan 50mg Tablet, 30 count each blister card.