Drug recall D-0303-2020

Class III Terminated reported Nov 13, 2019

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.

Reason for recall

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

Lots and codes

Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21

Recall details

Recalling firm
Sato Pharmaceutical Inc., Torrance, CA
Quantity
17,284 bottles
Distribution
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Type
Voluntary: Firm initiated
Recall initiated
October 1, 2019
Terminated
August 18, 2020

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