FDA recall D-0854-2017

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.

Reason for recall

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

Distribution

US: Hawaii, Guam, Saipan, SPI

Key facts

Status

Terminated

Initiation date

2017-02-16

Report date

2017-05-31

Termination date

2018-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2017