FDA recall D-0303-2020

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-10-01

Report date

2019-11-13

Termination date

2020-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2020