VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distrib…

Recall date

August 30, 2023

Source

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

Recall number

D-1149-2023

FDA classification

Class II

Brand / firm

VistaPharm LLC

Sold / distributed

Distributed nationwide to 68 consignees in the U.S.

Why it was recalled

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

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

What was recalled

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16