Sato Pharmaceutical Inc. recalls SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by
Recalled May 31, 2017 · FDA recall D-0855-2017 · 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
4,790 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
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
Manufacturer(s)
Sato Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →