PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: November 13, 2019 Initiated: October 1, 2019 #D-0303-2020

Product Description

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.

Details

Recalling Firm
Sato Pharmaceutical Inc.
Units Affected
17,284 bottles
Distribution
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Location
Torrance, CA

Frequently Asked Questions

What product 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.. Recalled by Sato Pharmaceutical Inc.. Units affected: 17,284 bottles.
Why was this product recalled?
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Low. Recall number: D-0303-2020.