FDAFDA · Food and drugs·Recall number D-0303-2020
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.
Published November 13, 2019 · Recall initiated: October 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SANKAIJO
- Manufacturer
- Sato Pharmaceutical Inc.
- Distributor
- Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
- Lot
- Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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