Sato Pharmaceutical Inc. recalls Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured b…

Recall date

October 1, 2019

Source

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

Recall number

D-0303-2020

FDA classification

Class III

Brand / firm

Sato Pharmaceutical Inc.

Sold / distributed

Nationwide in the USA and Guam and Saipan, Northern Mariana Islands

Why it was recalled

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.