Optic Splash Eye Drops 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 Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmace…
- Recall number
- D-0854-2017
- 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
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.
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