Sankaijo Tablet
FDA Recall NDC 49873-404
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sankaijo (NDC 49873-404). A significant event, classified as Class III, was initiated on Oct 01, 2019 by Sato Pharmaceutical Co., Ltd.. The reported reason for this action was: "Subpotent Drug: Formulated amount of sennosides component is less than labelled claim."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Oct 01, 2019
Nov 13, 2019
17,284 bottles
Recall Profile & Regulatory Data
Event ID
84019
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sato Pharmaceutical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Termination Date
Aug 18, 2020
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.
Batch or Lot Expiration Information
Lot# : TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Affected Packages Involved in this Recall
49873-404-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
