Prevacid 24HR delayed-release capsules recalled over manufacturing violations

Recall date

September 26, 2018

Source

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

Official notice title

GLAXOSMITHKLINE NEBRASKA recalls Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (N…

Recall number

D-0088-2019

FDA classification

Class II

Brand / firm

GLAXOSMITHKLINE NEBRASKA

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

CGMP deviations

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

What was recalled

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.