DORAMA-NEO Eye wash recalled over sterility concerns

Recall date

February 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sato Pharmaceutical Inc. recalls DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuti…

Recall number

D-0856-2017

FDA classification

Class II

Brand / firm

Sato Pharmaceutical Inc.

Sold / distributed

US: Hawaii, Guam, Saipan, SPI

Why it was recalled

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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