Sato Pharmaceutical Inc. Recalls

All product recalls associated with Sato Pharmaceutical Inc..

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Recall Summary

Total Recalls

8

Past Year

0

Class I (Serious)

0

Most Recent

Oct 2019

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–8 of 8 recalls

WAL-DRAM 2 Tablets (Sato) – Subpotent Drug (2019)

Subpotent Drug

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Zentrip Strips (Sato) – Subpotent Drug (2019)

Subpotent Drug

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Motion Sickness Tablets (Sato) – Subpotent Drug (2019)

Subpotent Drug

Class IIILow

FDAOct 1, 2019

Nationwide

• Sato Pharmaceutical Inc.

Motion Sickness Strips (Sato) – Subpotent Drug (2019)

Subpotent Drug

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Sankaijo Botanical Laxative (Sato) – Subpotent Formulation (2019)

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

Class IIILow

FDAOct 1, 2019Nationwide• Sato Pharmaceutical Inc.

Dorama-Neo Eye Wash (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Optic Splash Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Sato Clear Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

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Sato Pharmaceutical Inc. Recalls

Recall Summary

WAL-DRAM 2 Tablets (Sato) – Subpotent Drug (2019)

Zentrip Strips (Sato) – Subpotent Drug (2019)

Motion Sickness Tablets (Sato) – Subpotent Drug (2019)

Motion Sickness Strips (Sato) – Subpotent Drug (2019)

Sankaijo Botanical Laxative (Sato) – Subpotent Formulation (2019)

Dorama-Neo Eye Wash (Sato Pharmaceutical) – Sterility Concern (2017)

Optic Splash Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Sato Clear Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)