Why it was recalled
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
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.
Lot numbers, UPCs & expiration codes
Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
Where it was sold
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0303-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 1, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 17,284 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sato Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0303-2020, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84019
- Address
- 20695 S Western Ave Ste 240
- Code information
- Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21
- Postal code
- 90501-1834
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0303-2020
- Classification
- Class III
- Recalling firm
- Sato Pharmaceutical Inc.
- Product quantity
- 17,284 bottles
- Termination date
- Aug 18, 2020
- Reason for recall
- Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Guam and Saipan, Northern Mariana Islands
- Recall initiation date
- Oct 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2019