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,

FDA recall notice · announced November 13, 2019 · Sato Pharmaceutical

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Lot/code information: Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Quantity: 17,284 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0303-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.