Sato Pharmaceutical Inc. recalls DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceutic
Recalled May 31, 2017 · FDA recall D-0856-2017 · 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
14,325 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
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
Manufacturer(s)
Sato Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →