FDA-Drug2019-11-13Class III

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.

Sato Pharmaceutical Inc.
Hazard

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

Sold states
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Affected count
17,284 bottles
Manufactured in
20695 S Western Ave Ste 240, N/A, Torrance, CA, United States
Products
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.

Official notice

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

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