October 2019 FDA Recall Sankaijo by Sato Pharmaceutical Inc.
D-0303-2020 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Sato Pharmaceutical Inc. on October 1, 2019 for the product Sankaijo. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0303-2020
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
10-01-2019
11-13-2019
17,284 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sato Pharmaceutical Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
08-18-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
