FDA-Drug2017-05-31Class II
Optic Splash (naphazoline hydrochloride) 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 49873-501-01.
Sato Pharmaceutical Inc.
Hazard
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Sold states
US: Hawaii, Guam, Saipan, SPI
Affected count
10,130 bottles
Manufactured in
20695 S Western Ave Ste 240, Torrance, CA, United States
Products
Optic Splash (naphazoline hydrochloride) 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 49873-501-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2017Don't want to check this manually?
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