Drug 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.
D-0303-2020
Product summary
- Event
- Event 84019
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,284 bottles
- Official record key
drug-enforcement:D-0303-2020
Official wording
Reason: Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Code information: Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Distribution pattern: Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
Derived failure modes
-
Potency or specification failure
Subpotent