SATO CLEAR Redness Reliever 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 SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured b…
- Recall number
- D-0855-2017
- 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
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
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