Chlorhexidine Gluconate 0 recalled over manufacturing violations

Recall date

June 1, 2017

Source

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

Official notice title

Xttrium Laboratories Inc recalls Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mo…

Recall number

D-0938-2017

FDA classification

Class II

Brand / firm

Xttrium Laboratories Inc

Sold / distributed

Natiowide

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

Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16