Preferred Plus Dioctyl Liquid 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 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RI…

Recall number

D-1527-2019

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

Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16