Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Sankaijo BOTANICAL LAXATIVE (Docusate Sodium, Sennosides)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
49873-0404-01
Compare with the code on your package — it is the most precise check available.
Drug: Docusate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sankaijo docusate sodium, sennosides NDC 49873-0404 |
DOCUSATE SODIUM 8.33 mg/1; SENNOSIDES 1.36 mg/1 | Tablet Oral |
Sato Pharmaceutical Co., Ltd. | OTC |
- Recalling firm
- Sato Pharmaceutical Inc.
- NDC code
- 49873-404-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0303-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Docusate recalls
See all
Class II · Moderate risk
OneLAX Docusate Sodium Liquid
CGMP Deviations
Class II · Moderate risk
Docu Liquid
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Diocto Liquid Docusate Sodium Stool Softener
cGMP Deviations: Products may have microbial contamination.
Other recalls by Sato Pharmaceutical Inc.
All 2019 recalls
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class III · Low risk
Motion Sickness Strips
Subpotent Drug
Class III · Low risk
Wal-Dram 2
Subpotent Drug
Class III · Low risk
Motion Sickness
Subpotent Drug
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