Gericare Diocto Liquid Docusate Sodium Stool Softener recalled over manufacturing violations

Recall date

May 31, 2019

Source

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

Official notice title

Geritrex, LLC recalls Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals…

Recall number

D-1522-2019

FDA classification

Class II

Brand / firm

Geritrex, LLC

Sold / distributed

U.S.A. Nationwide

Why it was recalled

cGMP Deviations: Products may have microbial contamination.

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

What was recalled

Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16