D-0303-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- October 1, 2019
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,284 bottles
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.
Distribution Pattern
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Code Information
Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21