Recalls / Class III
Class IIID-0303-2020
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.
- Brand name
- Sankaijo
- Generic name
- Docusate Sodium, Sennosides
- Active ingredients
- Docusate Sodium, Sennosides
- Route
- Oral
- NDC
- 49873-404
- FDA application
- M007
- Affected lot / code info
- Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Why it was recalled
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Recalling firm
- Firm
- Sato Pharmaceutical Inc.
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20695 S Western Ave Ste 240, N/A, Torrance, California 90501-1834
Distribution
- Quantity
- 17,284 bottles
- Distribution pattern
- Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Timeline
- Recall initiated
- 2019-10-01
- FDA classified
- 2019-11-07
- Posted by FDA
- 2019-11-13
- Terminated
- 2020-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0303-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.