Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops Recalled by Sato Pharmaceutical Inc. Due to Lack of Assurance of Sterility: Firm failed to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sato Pharmaceutical Inc. directly.
Affected Products
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Quantity: 4,790 bottles
Why Was This Recalled?
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Where Was This Sold?
US: Hawaii, Guam, Saipan, SPI
About Sato Pharmaceutical Inc.
Sato Pharmaceutical Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report