Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DORAMA-NEO (naphazoline hydrochloride) Eye wash 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
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Quantity: 14,325 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