Sato Pharmaceutical Inc. recalls Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceu
Recalled May 31, 2017 · FDA recall D-0854-2017 · Sato Pharmaceutical
Hazard
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. · FDA Class II
Units
10,130 bottles
Sold at
US: Hawaii, Guam, Saipan, SPI
Description
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Product
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.
Manufacturer(s)
Sato Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →