D-0303-2020 Class III Terminated
FDA drug recall D-0303-2020 was initiated by Sato Pharmaceutical Inc. on Oct 1, 2019 and is designated Class III. Reason for recall: Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. The recall status is terminated (terminated Aug 18, 2020). Affected quantity: 17,284 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 1, 2019
- Termination Date
- Aug 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0303-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026